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

June 29, 2018 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Plovdiv, Bulgaria
        • UMHAT Sveti Georgi 3rd Clinical of Surgery
      • Rousse, Bulgaria
        • MHAT Rousse, 2nd Clinical of Surgery
      • Sofia, Bulgaria
        • CCB Ministry of Interior Clinical of Surgery
      • Sofia, Bulgaria
        • Multiprofile Hospital for Active Trt Emergency Med
      • Sofia, Bulgaria
        • UMHAT Queen Joanna-ISUL, Clinical of Surgery
  • France
      • Marseille, France
        • Hospital Saint Joseph Marseille
      • Nice, France
        • Hospital L'Archet II
      • Nimes, France
        • Chu Nimes
  • India
      • Ahmedabad, India
        • Medisurge Hospital Ahmedabad
      • Bangalore, India
        • Medisys Clinisearch India Pvt Ltd
      • Bangalore, India
        • MS Ramaiah Memorial Hospital Bangalore
      • Bangalore, India
        • Victoria Hospital Bangalore
      • Cochin, India
        • Amrita Institute of Medical Sciences, Cochin
      • Indore, India
        • Suyash Hospital Indore
      • Jaipur, India
        • SR Kalla General and Gastro Hospital
      • Lucknow, India
        • Lucknow Cancer Institute Lucknow
  • Lebanon
      • Beirut, Lebanon
        • Makassed General Hospital
      • Beirut, Lebanon
        • Al-Zahraa university Hospital
      • Beirut, Lebanon
        • Rafik Heriri University Hospital
      • Saida, Lebanon
        • Labib Medical Center
      • Saida, Lebanon
        • Hammound Hospital University Medical Center
  • Poland
      • Katowice, Poland
        • Slaski Uniwersytet Medyczny
      • Nowe Ogrody, Poland
        • Pomorskie Centrum Traumatologii
      • Warszawa, Poland
        • Katedra i Klinika Chirurgii Ogolnej
      • Warszawa, Poland
        • Samodzielny Publiczny
      • Wroclaw, Poland
        • Akademicki Szpital Kliniczn
  • Romania
      • Bucharest, Romania
        • Coltea Clinical Hospital
      • Bucharest, Romania
        • Fundeni Clinical Institute
      • Bucharest, Romania
        • Floreasca Clinical Emergency Hospital
      • Bucharest, Romania
        • University Emergency Hospital Bucharest
  • Russian Federation
      • Moscow, Russian Federation
        • City Clinical Hospital # 13
      • Moscow, Russian Federation
        • City Clinical Hospital # 1
      • Moscow, Russian Federation
        • FGU National Medical Surgery
      • Moscow, Russian Federation
        • Moscow City Clinical Hospital # 31
      • Smolensk, Russian Federation
        • SMO of Clinical Trials
      • Vladikavkas, Russian Federation
        • North-Ossetian Medical Academy
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Los Angeles, California, United States
        • Cedars-Sinai Medical Center Dept of Surgery
      • Palm Springs, California, United States
        • Michael S. Somero Research Division
    • Michigan
      • Detroit, Michigan, United States
        • Henry Ford Health System
    • Montana
      • Butte, Montana, United States
        • Mercury Street Medical Group
    • New Jersey
      • Somers Point, New Jersey, United States
        • South Jersey Infectious Disease
    • Ohio
      • Akron, Ohio, United States
        • Summa Health Systems
      • Columbus, Ohio, United States
        • Remington-Daviss Inc
      • Toledo, Ohio, United States
        • ID Clinical Research Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Meropenem
Drug: meropenem
IV TID
Other Names:
  • merrem
Experimental: NXL104/CAZ/MTZ
NXL104/ceftazidime + metronidazole
Drug: ceftazidime/NXL104 + metronidazole
IV TID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Clinical Response at the Test of Cure (TOC) Visit
Time Frame: Test of cure visit: 2 weeks post-therapy (Day 28)
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.
Test of cure visit: 2 weeks post-therapy (Day 28)
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline up to 6 weeks after last dose of study treatment (up to a maximum of 8 weeks)
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.
Baseline up to 6 weeks after last dose of study treatment (up to a maximum of 8 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Clinical Response at the End of Intravenous (IV) Therapy
Time Frame: End of IV therapy: From Day 5 to Day 14
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.
End of IV therapy: From Day 5 to Day 14
Number of Participants With Clinical Response at the Late Follow-up Visit
Time Frame: Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
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.
Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
Number of Participants With Microbiological Response at the Test of Cure Visit
Time Frame: Test of cure visit: 2 weeks post-therapy (Day 28)
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.
Test of cure visit: 2 weeks post-therapy (Day 28)
Number of Participants With Microbiological Response at the End of IV Therapy
Time Frame: End of IV therapy: From Day 5 to Day 14
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.
End of IV therapy: From Day 5 to Day 14
Number of Participants With Microbiological Response at the Late Follow-up Visit
Time Frame: Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
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)
Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
Number of Participants With Clinical Response in Clinically Evaluable (CE) Participants at the Test of Cure Visit
Time Frame: Test of cure visit: 2 weeks post-therapy (Day 28)
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.
Test of cure visit: 2 weeks post-therapy (Day 28)
Number of Participants With Clinical Response in CE Participants at the End of IV Therapy
Time Frame: End of IV therapy: From Day 5 to Day 14
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.
End of IV therapy: From Day 5 to Day 14
Number of Participants With Clinical Response in CE Participants at the Late Follow-up Visit
Time Frame: Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
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.
Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2009

Primary Completion (Actual)

November 30, 2009

Study Completion (Actual)

December 31, 2009

Study Registration Dates

First Submitted

September 11, 2008

First Submitted That Met QC Criteria

September 11, 2008

First Posted (Estimate)

September 15, 2008

Study Record Updates

Last Update Posted (Actual)

July 3, 2018

Last Update Submitted That Met QC Criteria

June 29, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NXL-104/2002
  • C3591014 (Other Identifier: Alias Study Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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