Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI
Primary Purpose
Urinary Tract Infections
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cefepime 1G - 2G / AAI101 0.5G - 0.75G
cefepime 1 g or cefepime 2 g
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Tract Infections
Eligibility Criteria
Inclusion criteria:
• Male or female patients with clinical signs and/or symptoms of cUTI or acute pyelonephritis that were expected to require hospitalization and initial treatment with at least 7 days of i.v.
antibiotics.
Exclusion criteria:
- Patients with concurrent infection that would interfere with evaluation of response to the study antibiotics;
- Patients needing concomitant systemic antimicrobial agents in addition to those designated in the various study treatment groups;
- Patients receiving effective antibacterial drug therapy for any indication for a continuous duration of >24 hours during the previous 72 hours before the study-qualifying baseline urine was obtained or receiving any amount of potentially therapeutic antibacterial therapy after collection of the pre-treatment baseline urine culture and before administration of the first dose of study drug;
- Patients likely to require the use of an antibiotic for cUTI or acute pyelonephritis prophylaxis during participation in the study;
- Patients with confirmed fungal urinary tract infection at the screening visit (with ≥103 fungal colony forming units [CFU]/mL); or
- Patients with intractable urinary infection at baseline that the Investigator anticipated would require >10 days of study drug therapy were excluded from participation
Sites / Locations
- Kromerizska nemocnice
- Jahn Ferenc Del-pesti Korhaz
- Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie, Klinika Chorob Wewnetrznych, Nefrologii i Transplantologii
- Fakultna nemocnica s poliklinikou J.A. Reimana Presov
- Chernihiv City Hospital #2 of Chernihiv City Council, department of Urology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cefepime 1G - 2G / AAI101 0.5G - 0.75G
cefepime monotherapy
Arm Description
cefepime 1 g or cefepime 2 g in combination with AAI101 500 mg or 750 mg
cefepime 1 g or cefepime 2 g
Outcomes
Primary Outcome Measures
Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population
Microbiological response is eradication for each baseline pathogen
Secondary Outcome Measures
Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population.
Microbiological response is eradication for each baseline pathogen
Full Information
NCT ID
NCT03680612
First Posted
September 19, 2018
Last Updated
September 20, 2018
Sponsor
Allecra
Collaborators
Medpace, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03680612
Brief Title
Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI
Official Title
Randomized, Double-Blind, Multi-Center Study of Cefepime/AAI101 in Hospitalized Adults With Complicated Urinary Tract Infections, Including Acute Pyelonephritis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 5, 2017 (Actual)
Primary Completion Date
February 14, 2018 (Actual)
Study Completion Date
February 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allecra
Collaborators
Medpace, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Phase 2, randomised, double-blind, 2-cohort study in hospitalised adults with complicated urinary tract infection (cUTI), including acute pyelonephritis. All study cohorts were randomised in a 2:1 ratio. Treatment duration for each cohort was 7 to 10 days. Patients were not permitted to switch to oral therapy.
Cohort 1: 15 patients treated with cefepime 1 g/AAI101 500 mg intravenous (i.v.) infusion over 2 hours once every 8 hours (q8h), and 7 patients treated with cefepime 1 g i.v. infusion over 2 hours q8h.
Cohort 2: 15 patients treated with cefepime 2 g/AAI101 750 mg i.v. infusion over 2 hours q8h, and 8 patients treated with cefepime 2 g i.v. infusion over 2 hours q8h.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cefepime 1G - 2G / AAI101 0.5G - 0.75G
Arm Type
Experimental
Arm Description
cefepime 1 g or cefepime 2 g in combination with AAI101 500 mg or 750 mg
Arm Title
cefepime monotherapy
Arm Type
Active Comparator
Arm Description
cefepime 1 g or cefepime 2 g
Intervention Type
Drug
Intervention Name(s)
Cefepime 1G - 2G / AAI101 0.5G - 0.75G
Other Intervention Name(s)
cefepime/AAI101 combination
Intervention Description
Experimental drug
Intervention Type
Drug
Intervention Name(s)
cefepime 1 g or cefepime 2 g
Other Intervention Name(s)
cefepime alone
Intervention Description
cefepime monotherapy
Primary Outcome Measure Information:
Title
Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population
Description
Microbiological response is eradication for each baseline pathogen
Time Frame
6 to 9 days post-End of Treatment
Secondary Outcome Measure Information:
Title
Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population.
Description
Microbiological response is eradication for each baseline pathogen
Time Frame
6 to 9 days post-End of Treatment
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:
• Male or female patients with clinical signs and/or symptoms of cUTI or acute pyelonephritis that were expected to require hospitalization and initial treatment with at least 7 days of i.v.
antibiotics.
Exclusion criteria:
Patients with concurrent infection that would interfere with evaluation of response to the study antibiotics;
Patients needing concomitant systemic antimicrobial agents in addition to those designated in the various study treatment groups;
Patients receiving effective antibacterial drug therapy for any indication for a continuous duration of >24 hours during the previous 72 hours before the study-qualifying baseline urine was obtained or receiving any amount of potentially therapeutic antibacterial therapy after collection of the pre-treatment baseline urine culture and before administration of the first dose of study drug;
Patients likely to require the use of an antibiotic for cUTI or acute pyelonephritis prophylaxis during participation in the study;
Patients with confirmed fungal urinary tract infection at the screening visit (with ≥103 fungal colony forming units [CFU]/mL); or
Patients with intractable urinary infection at baseline that the Investigator anticipated would require >10 days of study drug therapy were excluded from participation
Facility Information:
Facility Name
Kromerizska nemocnice
City
Kromeriz
ZIP/Postal Code
76701
Country
Czechia
Facility Name
Jahn Ferenc Del-pesti Korhaz
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie, Klinika Chorob Wewnetrznych, Nefrologii i Transplantologii
City
Warsaw
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Fakultna nemocnica s poliklinikou J.A. Reimana Presov
City
Prešov
ZIP/Postal Code
081 81
Country
Slovakia
Facility Name
Chernihiv City Hospital #2 of Chernihiv City Council, department of Urology
City
Chernihiv
ZIP/Postal Code
14034
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI
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