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Trial of Colistin Versus Meropenem in Ventilator-associated Pneumonia (VAP) (CR-GNB)

NCT01292031 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2016-02-03

No results posted yet for this study

Summary

1. To demonstrate that colistin iv. is not inferior to meropenem in empiric treatment of VAP regarding the final point of primary efficacy: mortality in the 28 subsequent days and clinical healing in patients clinically evaluated.
2. To compare the safety of treatment with colistin vs meropenem in VAP.
3. To compare microbiological efficacy of treatment with colistin vs meropenem in VAP

Conditions

  • Ventilator-associated Bacterial Pneumonia

Interventions

DRUG

Colistin

Colistin 4.5 MU/iv plus Colistin 3 MU/iv./8 h. 30 minutes infusion

DRUG

Meropenem

Meropenem 2 g/iv/ 8 h. 30 minutes infusion

Sponsors & Collaborators

  • European Commission

    collaborator OTHER

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Principal Investigators

  • José Miguel Cisneros-Herreros, PhD · Andaluz Health Service

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Greece
  • Italy
  • Spain

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 NCT01292031 on ClinicalTrials.gov