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Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections

NCT01499290 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 493

Last updated 2017-09-06

Study results available
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Summary

The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus Metronidazole compared to Meropenem for treating hospitalized patients with complicated intra-abdominal infections.

Conditions

  • Complicated Intra-Abdominal Infection

Interventions

DRUG

CAZ-AVI

Ceftazidime 2000 mg and 500 mg of avibactam

DRUG

Metronidazole

500 mg of Metronidazole

DRUG

Meropenem

1 gram of Meropenem

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Paul Newell, MBBS, MRCP · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States
  • Argentina
  • Bulgaria
  • Croatia
  • Czechia
  • Hungary
  • India
  • Israel
  • Latvia
  • Malaysia
  • Mexico
  • Netherlands
  • Peru
  • Romania
  • Russia
  • South Africa
  • Spain
  • Taiwan
  • Thailand
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01499290 on ClinicalTrials.gov