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Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)

Primary Purpose

Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ceftazidime - Avibactam ( CAZ-AVI)
Doripenem
Either switch to oral therapy: 500 mg of Ciprofloxacin (oral)
or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis focused on measuring Ceftazidime, Avibactam, Doripenem, Ciprofloxacin, sulfamethoxazole/trimethoprim, Anti-Infective Agents, Complicated Urinary Tract Infection,Acute Pyelonephritis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 to 90 years of age inclusive
  • Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after
  • Has pyuria with >/= 10 WBCs (white blood cell) and has a positive urine culture within 48 hours of enrollment containing >/=10 to the fifth CFU (colony forming unit ) /ml of a recognized uropathogen known to be susceptible to IV study therapy (CAZ-AVI and doripenem)
  • Demonstrates either acute pyelonephritis or complicated lower UTI without pyelonephritis

Exclusion Criteria:

  • Urine pathogen is a Gram-positive pathogen or a uropathogen resistant to CAZ-AVI or doripenem
  • Patient's urine culture at study entry isolates more than 2 microorganisms regardless of colony count or patient has a confirmed fungal UTI
  • Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant
  • Patient is immunocompromised
  • Patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness including septic shock which is associated with a high risk of mortality

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ceftazidime - Avibactam ( CAZ-AVI)

Doripenem

Arm Description

IV treatment

IV treatment

Outcomes

Primary Outcome Measures

Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test
Number of patients with symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) with resolution of or improvement in flank pain based on the patient-reported symptom assessment response at the Day 5 visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).
Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test
Number of patients with both a favorable per patient microbiological response and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the TOC visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).
Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test
Number of patients with a favorable per patient microbiological response at TOC. The primary efficacy outcome variable for ROW is the proportion of patients with a favorable per-patient microbiological response at the TOC visit in the mMITT analysis set.

Secondary Outcome Measures

Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)
Number of patients with a favorable per-patient microbiological response at EOT (IV)
Per-patient Microbiological Response at LFU (mMITT Analysis Set)
Number of patients with a favorable per patient microbiological response at LFU
Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set)
Number of patients with a favorable per-patient microbiological response at EOT (IV)
Per-patient Microbiological Response at TOC (ME at TOC Analysis Set)
Number of patients with a favorable per patient microbiological response at TOC
Per-patient Microbiological Response at LFU (ME at LFU Analysis Set)
Number of patients with a favorable per patient microbiological response at LFU
Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)
Number of patients with a favorable per-patient microbiological response at EOT (IV)
Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set)
Number of patients with a favorable per patient microbiological response at TOC
Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set)
Number of patients with a favorable per patient microbiological response at LFU
Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set)
Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Investigator Determined Clinical Response at TOC (mMITT Analysis Set)
Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Investigator Determined Clinical Response at LFU (mMITT Analysis Set)
Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set)
Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set)
Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set)
Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)
Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set)
Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set)
Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set)
Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set)
Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set)
Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)
Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)
Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)
Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.
Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)
Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set.
Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)
Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set.
Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)
Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set.
Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set)
Time to first defervescence while on IV study therapy in patients in the mMITT analysis set who have fever at study entry.
Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set)
Time to first defervescence while on IV study therapy in patients in the ME at TOC analysis set who have fever at study entry.
Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set)
Time to first defervescence while on IV study therapy in patients in the Extended ME at TOC analysis set who have fever at study entry.
Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set)
Time to first defervescence while on IV study therapy in patients in the CE at TOC analysis set who have fever at study entry.
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set)
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set)
Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set)
Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set)
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set)
Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set)
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set)
Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set)
Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set)
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set for blood only
Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set)
Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set for blood only
Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set)
Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set for blood only
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set)
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set for blood only
Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set)
Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set for blood only
Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set)
Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set for blood only
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set)
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set for blood only
Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set)
Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set for blood only
Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set)
Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set for blood only
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the mMITT analysis set
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the Extended ME at TOC analysis set
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the ME at TOC analysis set
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the mMITT analysis set
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the Extended ME at TOC analysis set
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the ME at TOC analysis set
Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set)
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.

Full Information

First Posted
May 15, 2012
Last Updated
August 31, 2017
Sponsor
Pfizer
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01599806
Brief Title
Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)
Official Title
A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, Formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Forest Laboratories

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis
Detailed Description
A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
Keywords
Ceftazidime, Avibactam, Doripenem, Ciprofloxacin, sulfamethoxazole/trimethoprim, Anti-Infective Agents, Complicated Urinary Tract Infection,Acute Pyelonephritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
641 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ceftazidime - Avibactam ( CAZ-AVI)
Arm Type
Experimental
Arm Description
IV treatment
Arm Title
Doripenem
Arm Type
Active Comparator
Arm Description
IV treatment
Intervention Type
Drug
Intervention Name(s)
Ceftazidime - Avibactam ( CAZ-AVI)
Intervention Description
Ceftazidime 2000 mg and 500 mg of avibactam. Patients randomized to receive CAZ-AVI will receive an infusion of CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 120 minutes
Intervention Type
Drug
Intervention Name(s)
Doripenem
Intervention Description
500 mg of Doripenem. Patients randomized to receive Doripenem will receive an infusion of Doripenem 500 mg every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 60 minutes
Intervention Type
Drug
Intervention Name(s)
Either switch to oral therapy: 500 mg of Ciprofloxacin (oral)
Intervention Description
Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement
Intervention Type
Drug
Intervention Name(s)
or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)
Intervention Description
Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement
Primary Outcome Measure Information:
Title
Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test
Description
Number of patients with symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) with resolution of or improvement in flank pain based on the patient-reported symptom assessment response at the Day 5 visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).
Time Frame
At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time.
Title
Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test
Description
Number of patients with both a favorable per patient microbiological response and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the TOC visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).
Time Frame
At TOC visit. TOC visit is 21 to 25 days from Randomization.
Title
Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test
Description
Number of patients with a favorable per patient microbiological response at TOC. The primary efficacy outcome variable for ROW is the proportion of patients with a favorable per-patient microbiological response at the TOC visit in the mMITT analysis set.
Time Frame
At TOC visit. TOC visit is 21 to 25 days from Randomization.
Secondary Outcome Measure Information:
Title
Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)
Description
Number of patients with a favorable per-patient microbiological response at EOT (IV)
Time Frame
At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Title
Per-patient Microbiological Response at LFU (mMITT Analysis Set)
Description
Number of patients with a favorable per patient microbiological response at LFU
Time Frame
At LFU visit. LFU visit is 45 to 52 days from Randomization.
Title
Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set)
Description
Number of patients with a favorable per-patient microbiological response at EOT (IV)
Time Frame
At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Title
Per-patient Microbiological Response at TOC (ME at TOC Analysis Set)
Description
Number of patients with a favorable per patient microbiological response at TOC
Time Frame
At TOC visit. TOC visit is 21 to 25 days from Randomization.
Title
Per-patient Microbiological Response at LFU (ME at LFU Analysis Set)
Description
Number of patients with a favorable per patient microbiological response at LFU
Time Frame
At LFU visit. LFU visit is 45 to 52 days from Randomization.
Title
Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)
Description
Number of patients with a favorable per-patient microbiological response at EOT (IV)
Time Frame
At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Title
Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set)
Description
Number of patients with a favorable per patient microbiological response at TOC
Time Frame
At TOC visit. TOC visit is 21 to 25 days from Randomization.
Title
Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set)
Description
Number of patients with a favorable per patient microbiological response at LFU
Time Frame
At LFU visit. LFU visit is 45 to 52 days from Randomization.
Title
Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set)
Description
Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Time Frame
At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Title
Investigator Determined Clinical Response at TOC (mMITT Analysis Set)
Description
Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Time Frame
At TOC visit. TOC visit is 21 to 25 days from Randomization.
Title
Investigator Determined Clinical Response at LFU (mMITT Analysis Set)
Description
Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Time Frame
At LFU visit. LFU visit is 45 to 52 days from Randomization.
Title
Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set)
Description
Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Time Frame
At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Title
Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set)
Description
Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Time Frame
At TOC visit. TOC visit is 21 to 25 days from Randomization.
Title
Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set)
Description
Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Time Frame
At LFU visit. LFU visit is 45 to 52 days from Randomization.
Title
Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)
Description
Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Time Frame
At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Title
Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set)
Description
Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Time Frame
At TOC visit. TOC visit is 21 to 25 days from Randomization.
Title
Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set)
Description
Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Time Frame
At LFU visit. LFU visit is 45 to 52 days from Randomization.
Title
Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set)
Description
Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Time Frame
At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Title
Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set)
Description
Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Time Frame
At TOC visit. TOC visit is 21 to 25 days from Randomization.
Title
Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set)
Description
Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
Time Frame
At LFU visit. LFU visit is 45 to 52 days from Randomization.
Title
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)
Description
Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.
Time Frame
At TOC visit. TOC visit is 21 to 25 days from Randomization.
Title
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)
Description
Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.
Time Frame
At TOC visit. TOC visit is 21 to 25 days from Randomization.
Title
Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)
Description
Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.
Time Frame
At TOC visit. TOC visit is 21 to 25 days from Randomization.
Title
Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)
Description
Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set.
Time Frame
At TOC visit. TOC visit is 21 to 25 days from Randomization.
Title
Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)
Description
Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set.
Time Frame
At TOC visit. TOC visit is 21 to 25 days from Randomization.
Title
Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)
Description
Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set.
Time Frame
At TOC visit. TOC visit is 21 to 25 days from Randomization.
Title
Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set)
Description
Time to first defervescence while on IV study therapy in patients in the mMITT analysis set who have fever at study entry.
Time Frame
Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.
Title
Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set)
Description
Time to first defervescence while on IV study therapy in patients in the ME at TOC analysis set who have fever at study entry.
Time Frame
Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.
Title
Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set)
Description
Time to first defervescence while on IV study therapy in patients in the Extended ME at TOC analysis set who have fever at study entry.
Time Frame
Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.
Title
Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set)
Description
Time to first defervescence while on IV study therapy in patients in the CE at TOC analysis set who have fever at study entry.
Time Frame
Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.
Title
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set)
Description
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set
Time Frame
At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Title
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set)
Description
Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set
Time Frame
At TOC visit. TOC visit is 21 to 25 days from Randomization
Title
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set)
Description
Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set
Time Frame
At LFU visit. LFU visit is 45 to 52 days from Randomization
Title
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set)
Description
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set
Time Frame
At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Title
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Description
Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set
Time Frame
At TOC visit. TOC visit is 21 to 25 days from Randomization.
Title
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set)
Description
Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set
Time Frame
At LFU visit. LFU visit is 45 to 52 days from Randomization.
Title
Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set)
Description
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set
Time Frame
At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Title
Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set)
Description
Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set
Time Frame
At TOC visit. TOC visit is 21 to 25 days from Randomization.
Title
Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set)
Description
Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set
Time Frame
At LFU visit. LFU visit is 45 to 52 days from Randomization.
Title
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set)
Description
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set for blood only
Time Frame
At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Title
Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set)
Description
Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set for blood only
Time Frame
At TOC visit. TOC visit is 21 to 25 days from Randomization
Title
Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set)
Description
Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set for blood only
Time Frame
At LFU visit. LFU visit is 45 to 52 days from Randomization
Title
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set)
Description
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set for blood only
Time Frame
At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Title
Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set)
Description
Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set for blood only
Time Frame
At TOC visit. TOC visit is 21 to 25 days from Randomization.
Title
Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set)
Description
Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set for blood only
Time Frame
At LFU visit. LFU visit is 45 to 52 days from Randomization.
Title
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set)
Description
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set for blood only
Time Frame
At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
Title
Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set)
Description
Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set for blood only
Time Frame
At TOC visit. TOC visit is 21 to 25 days from Randomization.
Title
Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set)
Description
Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set for blood only
Time Frame
At LFU visit. LFU visit is 45 to 52 days from Randomization.
Title
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Description
Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the mMITT analysis set
Time Frame
At TOC visit. TOC visit is 21 to 25 days from Randomization
Title
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Description
Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the Extended ME at TOC analysis set
Time Frame
At TOC visit. TOC visit is 21 to 25 days from Randomization
Title
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Description
Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the ME at TOC analysis set
Time Frame
At TOC visit. TOC visit is 21 to 25 days from Randomization
Title
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Description
Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the mMITT analysis set
Time Frame
At TOC visit. TOC visit is 21 to 25 days from Randomization
Title
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Description
Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the Extended ME at TOC analysis set
Time Frame
At TOC visit. TOC visit is 21 to 25 days from Randomization
Title
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Description
Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the ME at TOC analysis set
Time Frame
At TOC visit. TOC visit is 21 to 25 days from Randomization
Title
Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set)
Description
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
Time Frame
within 15 minutes before/after dose
Title
Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set)
Description
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
Time Frame
Between 30 to 90 minutes after dose
Title
Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set)
Description
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
Time Frame
Between 300 to 360 minutes after dose
Title
Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set)
Description
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
Time Frame
within 15 minutes before/after dose
Title
Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set)
Description
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
Time Frame
Between 30 to 90 minutes after dose
Title
Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set)
Description
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
Time Frame
Between 300 to 360 minutes after dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 to 90 years of age inclusive Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after Has pyuria with >/= 10 WBCs (white blood cell) and has a positive urine culture within 48 hours of enrollment containing >/=10 to the fifth CFU (colony forming unit ) /ml of a recognized uropathogen known to be susceptible to IV study therapy (CAZ-AVI and doripenem) Demonstrates either acute pyelonephritis or complicated lower UTI without pyelonephritis Exclusion Criteria: Urine pathogen is a Gram-positive pathogen or a uropathogen resistant to CAZ-AVI or doripenem Patient's urine culture at study entry isolates more than 2 microorganisms regardless of colony count or patient has a confirmed fungal UTI Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant Patient is immunocompromised Patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness including septic shock which is associated with a high risk of mortality
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Newell, MBBS, MRCP
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Indiana
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Rosario
Country
Argentina
Facility Name
Research Site
City
Pazardzhik
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Veliko Tarnovo
Country
Bulgaria
Facility Name
Research Site
City
Slavonski Brod
Country
Croatia
Facility Name
Research Site
City
Zadar
Country
Croatia
Facility Name
Research Site
City
Zagreb
Country
Croatia
Facility Name
Research Site
City
Liberec
Country
Czechia
Facility Name
Research Site
City
Praha
Country
Czechia
Facility Name
Research Site
City
Hamburg
Country
Germany
Facility Name
Research Site
City
Haifa
Country
Israel
Facility Name
Research Site
City
Kfar-saba
Country
Israel
Facility Name
Research Site
City
Modena
Country
Italy
Facility Name
Research Site
City
Busan
Country
Korea, Republic of
Facility Name
Research Site
City
Jeonnam
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Cuernavaca, MOR
Country
Mexico
Facility Name
Research Site
City
Guadalajara
Country
Mexico
Facility Name
Research Site
City
Zapopan
Country
Mexico
Facility Name
Research Site
City
Arequipa
Country
Peru
Facility Name
Research Site
City
Cercardo de Lima
Country
Peru
Facility Name
Research Site
City
Cusco
Country
Peru
Facility Name
Research Site
City
Lima
Country
Peru
Facility Name
Research Site
City
Trujillo
Country
Peru
Facility Name
Research Site
City
Białystok
Country
Poland
Facility Name
Research Site
City
Sochaczew
Country
Poland
Facility Name
Research Site
City
Wrocław
Country
Poland
Facility Name
Research Site
City
Bucharest
Country
Romania
Facility Name
Research Site
City
Bucuresti
Country
Romania
Facility Name
Research Site
City
Oradea
Country
Romania
Facility Name
Research Site
City
Sibiu
Country
Romania
Facility Name
Research Site
City
Timisoara
Country
Romania
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
Nizhniy Novgorod
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Smolensk
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Research Site
City
St.-Petersburg,
Country
Russian Federation
Facility Name
Research Site
City
Tomsk
Country
Russian Federation
Facility Name
Research Site
City
Velikiy Novgorod
Country
Russian Federation
Facility Name
Research Site
City
Alicante
Country
Spain
Facility Name
Research Site
City
Alzira (Valencia)
Country
Spain
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Elche
Country
Spain
Facility Name
Research Site
City
Granada
Country
Spain
Facility Name
Research Site
City
Terrassa
Country
Spain
Facility Name
Research Site
City
Kaohsiung
Country
Taiwan
Facility Name
Research Site
City
Taipei
Country
Taiwan
Facility Name
Research Site
City
Chernivtsi
Country
Ukraine
Facility Name
Research Site
City
Ivano-Frankivsk
Country
Ukraine
Facility Name
Research Site
City
Kharkiv
Country
Ukraine
Facility Name
Research Site
City
Kyiv
Country
Ukraine
Facility Name
Research Site
City
Lutsk
Country
Ukraine
Facility Name
Research Site
City
Simferopol
Country
Ukraine
Facility Name
Research Site
City
Vinnytsia
Country
Ukraine
Facility Name
Research Site
City
Zaporizhzhya
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
32602065
Citation
Cheng K, Newell P, Chow JW, Broadhurst H, Wilson D, Yates K, Wardman A. Safety Profile of Ceftazidime-Avibactam: Pooled Data from the Adult Phase II and Phase III Clinical Trial Programme. Drug Saf. 2020 Aug;43(8):751-766. doi: 10.1007/s40264-020-00934-3.
Results Reference
derived
PubMed Identifier
30221827
Citation
Li J, Lovern M, Green ML, Chiu J, Zhou D, Comisar C, Xiong Y, Hing J, MacPherson M, Wright JG, Riccobene T, Carrothers TJ, Das S. Ceftazidime-Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups. Clin Transl Sci. 2019 Mar;12(2):151-163. doi: 10.1111/cts.12585. Epub 2018 Sep 28.
Results Reference
derived
PubMed Identifier
30061279
Citation
Nichols WW, Stone GG, Newell P, Broadhurst H, Wardman A, MacPherson M, Yates K, Riccobene T, Critchley IA, Das S. Ceftazidime-Avibactam Susceptibility Breakpoints against Enterobacteriaceae and Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2018 Oct 24;62(11):e02590-17. doi: 10.1128/AAC.02590-17. Print 2018 Nov.
Results Reference
derived
PubMed Identifier
29912399
Citation
Stone GG, Newell P, Gasink LB, Broadhurst H, Wardman A, Yates K, Chen Z, Song J, Chow JW. Clinical activity of ceftazidime/avibactam against MDR Enterobacteriaceae and Pseudomonas aeruginosa: pooled data from the ceftazidime/avibactam Phase III clinical trial programme. J Antimicrob Chemother. 2018 Sep 1;73(9):2519-2523. doi: 10.1093/jac/dky204.
Results Reference
derived
PubMed Identifier
27313268
Citation
Wagenlehner FM, Sobel JD, Newell P, Armstrong J, Huang X, Stone GG, Yates K, Gasink LB. Ceftazidime-avibactam Versus Doripenem for the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis: RECAPTURE, a Phase 3 Randomized Trial Program. Clin Infect Dis. 2016 Sep 15;63(6):754-762. doi: 10.1093/cid/ciw378. Epub 2016 Jun 16.
Results Reference
derived

Learn more about this trial

Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)

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