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Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections

Primary Purpose

Complicated Intra-abdominal Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ceftazidime/NXL104 + metronidazole
meropenem
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complicated Intra-abdominal Infections

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • complicated intra-abdominal infections

Exclusion Criteria:

  • infections limited to hollow viscus
  • ischemic bowel disease without perforation
  • acute suppurative cholangitis
  • acute necrotizing pancreatitis
  • pts to undergo stated abdominal repair, open abdomen technique or marsupialization
  • Apache II >25

Sites / Locations

  • University of Southern California
  • Cedars-Sinai Medical Center Dept of Surgery
  • Michael S. Somero Research Division
  • Henry Ford Health System
  • Mercury Street Medical Group
  • South Jersey Infectious Disease
  • Summa Health Systems
  • Remington-Daviss Inc
  • ID Clinical Research Ltd
  • UMHAT Sveti Georgi 3rd Clinical of Surgery
  • MHAT Rousse, 2nd Clinical of Surgery
  • CCB Ministry of Interior Clinical of Surgery
  • Multiprofile Hospital for Active Trt Emergency Med
  • UMHAT Queen Joanna-ISUL, Clinical of Surgery
  • Hospital Saint Joseph Marseille
  • Hospital L'Archet II
  • CHU Nimes
  • Medisurge Hospital Ahmedabad
  • Medisys Clinisearch India Pvt Ltd
  • MS Ramaiah Memorial Hospital Bangalore
  • Victoria Hospital Bangalore
  • Amrita Institute of Medical Sciences, Cochin
  • Suyash Hospital Indore
  • SR Kalla General and Gastro Hospital
  • Lucknow Cancer Institute Lucknow
  • Al-Zahraa university Hospital
  • Makassed General Hospital
  • Rafik Heriri University Hospital
  • Hammound Hospital University Medical Center
  • Labib Medical Center
  • Slaski Uniwersytet Medyczny
  • Pomorskie Centrum Traumatologii
  • Katedra i Klinika Chirurgii Ogolnej
  • Samodzielny Publiczny
  • Akademicki Szpital Kliniczn
  • Coltea Clinical Hospital
  • Floreasca Clinical Emergency Hospital
  • Fundeni Clinical Institute
  • University Emergency Hospital Bucharest
  • City Clinical Hospital # 13
  • City Clinical Hospital # 1
  • FGU National Medical Surgery
  • Moscow City Clinical Hospital # 31
  • SMO of Clinical Trials
  • North-Ossetian Medical Academy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NXL104/CAZ/MTZ

Meropenem

Arm Description

NXL104/ceftazidime + metronidazole

Outcomes

Primary Outcome Measures

Number of Participants With Clinical Response at the Test of Cure (TOC) Visit
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were microbiologically evaluable (ME) at baseline.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 weeks after last dose of study treatment that were absent before treatment or that worsened relative to pretreatment state.

Secondary Outcome Measures

Number of Participants With Clinical Response at the End of Intravenous (IV) Therapy
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were ME at baseline.
Number of Participants With Clinical Response at the Late Follow-up Visit
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were ME at baseline.
Number of Participants With Microbiological Response at the Test of Cure Visit
Microbiological response was defined as eradication of pathogen identified (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication of pathogens (absence of material to culture in a participant who had responded clinically to treatment). This clinical response was measured in participants who were ME at baseline.
Number of Participants With Microbiological Response at the End of IV Therapy
Microbiological response was defined as eradication of pathogen identified (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication of pathogens (absence of material to culture in a participant who had responded clinically to treatment). This clinical response was measured in participants who were ME at baseline.
Number of Participants With Microbiological Response at the Late Follow-up Visit
Favorable: eradication (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication (absence of material to culture in a patient who had responded clinically to treatment)
Number of Participants With Clinical Response in Clinically Evaluable (CE) Participants at the Test of Cure Visit
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required.
Number of Participants With Clinical Response in CE Participants at the End of IV Therapy
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required.
Number of Participants With Clinical Response in CE Participants at the Late Follow-up Visit
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required.

Full Information

First Posted
September 11, 2008
Last Updated
June 29, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00752219
Brief Title
Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections
Official Title
A Prospective, Multicenter, Double-blind, Randomized, Comparative Study to Estimate the Safety, Tolerability and Efficacy of NXL104/Ceftazidime Plus Metronidazole vs. Meropenem in the Treatment of Complicated Intra-abdominal Infections in Hospitalized Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 31, 2009 (Actual)
Primary Completion Date
November 30, 2009 (Actual)
Study Completion Date
December 31, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated intra-abdominal infections as compared to a comparator group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complicated Intra-abdominal Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NXL104/CAZ/MTZ
Arm Type
Experimental
Arm Description
NXL104/ceftazidime + metronidazole
Arm Title
Meropenem
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ceftazidime/NXL104 + metronidazole
Intervention Description
IV TID
Intervention Type
Drug
Intervention Name(s)
meropenem
Other Intervention Name(s)
merrem
Intervention Description
IV TID
Primary Outcome Measure Information:
Title
Number of Participants With Clinical Response at the Test of Cure (TOC) Visit
Description
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were microbiologically evaluable (ME) at baseline.
Time Frame
Test of cure visit: 2 weeks post-therapy (Day 28)
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 weeks after last dose of study treatment that were absent before treatment or that worsened relative to pretreatment state.
Time Frame
Baseline up to 6 weeks after last dose of study treatment (up to a maximum of 8 weeks)
Secondary Outcome Measure Information:
Title
Number of Participants With Clinical Response at the End of Intravenous (IV) Therapy
Description
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were ME at baseline.
Time Frame
End of IV therapy: From Day 5 to Day 14
Title
Number of Participants With Clinical Response at the Late Follow-up Visit
Description
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were ME at baseline.
Time Frame
Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
Title
Number of Participants With Microbiological Response at the Test of Cure Visit
Description
Microbiological response was defined as eradication of pathogen identified (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication of pathogens (absence of material to culture in a participant who had responded clinically to treatment). This clinical response was measured in participants who were ME at baseline.
Time Frame
Test of cure visit: 2 weeks post-therapy (Day 28)
Title
Number of Participants With Microbiological Response at the End of IV Therapy
Description
Microbiological response was defined as eradication of pathogen identified (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication of pathogens (absence of material to culture in a participant who had responded clinically to treatment). This clinical response was measured in participants who were ME at baseline.
Time Frame
End of IV therapy: From Day 5 to Day 14
Title
Number of Participants With Microbiological Response at the Late Follow-up Visit
Description
Favorable: eradication (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication (absence of material to culture in a patient who had responded clinically to treatment)
Time Frame
Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
Title
Number of Participants With Clinical Response in Clinically Evaluable (CE) Participants at the Test of Cure Visit
Description
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required.
Time Frame
Test of cure visit: 2 weeks post-therapy (Day 28)
Title
Number of Participants With Clinical Response in CE Participants at the End of IV Therapy
Description
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required.
Time Frame
End of IV therapy: From Day 5 to Day 14
Title
Number of Participants With Clinical Response in CE Participants at the Late Follow-up Visit
Description
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required.
Time Frame
Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: complicated intra-abdominal infections Exclusion Criteria: infections limited to hollow viscus ischemic bowel disease without perforation acute suppurative cholangitis acute necrotizing pancreatitis pts to undergo stated abdominal repair, open abdomen technique or marsupialization Apache II >25
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars-Sinai Medical Center Dept of Surgery
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Michael S. Somero Research Division
City
Palm Springs
State/Province
California
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Mercury Street Medical Group
City
Butte
State/Province
Montana
Country
United States
Facility Name
South Jersey Infectious Disease
City
Somers Point
State/Province
New Jersey
Country
United States
Facility Name
Summa Health Systems
City
Akron
State/Province
Ohio
Country
United States
Facility Name
Remington-Daviss Inc
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
ID Clinical Research Ltd
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
UMHAT Sveti Georgi 3rd Clinical of Surgery
City
Plovdiv
Country
Bulgaria
Facility Name
MHAT Rousse, 2nd Clinical of Surgery
City
Rousse
Country
Bulgaria
Facility Name
CCB Ministry of Interior Clinical of Surgery
City
Sofia
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Trt Emergency Med
City
Sofia
Country
Bulgaria
Facility Name
UMHAT Queen Joanna-ISUL, Clinical of Surgery
City
Sofia
Country
Bulgaria
Facility Name
Hospital Saint Joseph Marseille
City
Marseille
Country
France
Facility Name
Hospital L'Archet II
City
Nice
Country
France
Facility Name
CHU Nimes
City
Nimes
Country
France
Facility Name
Medisurge Hospital Ahmedabad
City
Ahmedabad
Country
India
Facility Name
Medisys Clinisearch India Pvt Ltd
City
Bangalore
Country
India
Facility Name
MS Ramaiah Memorial Hospital Bangalore
City
Bangalore
Country
India
Facility Name
Victoria Hospital Bangalore
City
Bangalore
Country
India
Facility Name
Amrita Institute of Medical Sciences, Cochin
City
Cochin
Country
India
Facility Name
Suyash Hospital Indore
City
Indore
Country
India
Facility Name
SR Kalla General and Gastro Hospital
City
Jaipur
Country
India
Facility Name
Lucknow Cancer Institute Lucknow
City
Lucknow
Country
India
Facility Name
Al-Zahraa university Hospital
City
Beirut
Country
Lebanon
Facility Name
Makassed General Hospital
City
Beirut
Country
Lebanon
Facility Name
Rafik Heriri University Hospital
City
Beirut
Country
Lebanon
Facility Name
Hammound Hospital University Medical Center
City
Saida
Country
Lebanon
Facility Name
Labib Medical Center
City
Saida
Country
Lebanon
Facility Name
Slaski Uniwersytet Medyczny
City
Katowice
Country
Poland
Facility Name
Pomorskie Centrum Traumatologii
City
Nowe Ogrody
Country
Poland
Facility Name
Katedra i Klinika Chirurgii Ogolnej
City
Warszawa
Country
Poland
Facility Name
Samodzielny Publiczny
City
Warszawa
Country
Poland
Facility Name
Akademicki Szpital Kliniczn
City
Wroclaw
Country
Poland
Facility Name
Coltea Clinical Hospital
City
Bucharest
Country
Romania
Facility Name
Floreasca Clinical Emergency Hospital
City
Bucharest
Country
Romania
Facility Name
Fundeni Clinical Institute
City
Bucharest
Country
Romania
Facility Name
University Emergency Hospital Bucharest
City
Bucharest
Country
Romania
Facility Name
City Clinical Hospital # 13
City
Moscow
Country
Russian Federation
Facility Name
City Clinical Hospital # 1
City
Moscow
Country
Russian Federation
Facility Name
FGU National Medical Surgery
City
Moscow
Country
Russian Federation
Facility Name
Moscow City Clinical Hospital # 31
City
Moscow
Country
Russian Federation
Facility Name
SMO of Clinical Trials
City
Smolensk
Country
Russian Federation
Facility Name
North-Ossetian Medical Academy
City
Vladikavkas
Country
Russian Federation

12. IPD Sharing Statement

Citations:
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

Learn more about this trial

Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections

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