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

Phase 3CompletedNCT01292031

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla232 enrolled

Overview

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

Study drugs: Patients will be randomized a 1:1 rate and open label fashion to two interventions: group 1: colistin loading dose followed by colistin infusion iv/8h or group 2: meropenem 2 g/iv/ 8 h. The overall treatment time will be a minimum of 8 days. Follow-up visits will be performed at baseline, 72 h, 8 days, the end of treatment, and 28 days from recruitment ICU discharge, hospital discharge or death.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

232

Conditions

Ventilator-associated Bacterial Pneumonia

Interventions

ColistinDRUG

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

MeropenemDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Age ≥ 18 years with clinical and radiological criteria of VAP. The women of childbearing age (not surgically sterilized and in the period between menarche and 1 year after the menopause) must have a negative test of pregnancy in urine at the time of recruitment. The patient or his/her legal representative must sign a document of informed consent approved by the Ethics Review Committee. Exclusion Criteria: Hypersensitivity to the two antimicrobials of the study (colistin/meropenem). Renal insufficiency in substitute treatment. Corporal weight \<40 kg or \>150 kg. Patients previously included in another clinical trial.

Locations (33)

Outcomes

Primary Outcomes

Number of patients who die as a measure of efficacy

Demostrate that colistin iv. is not inferior to meropenen in empiric treatment of VAP regarding the final point of primary efficacy: mortality in the 28 subsequent days

Time frame: 28 days

Secondary Outcomes

Number of patients with clinical healing as a measure of efficacy

Demostrate that colistin is not inferior to meropenem in empiric treatment of VAP regarding efficacy: clinical healing in patients clinically evaluated

Time frame: 28 days

Microbiological resolution as a measure of microbiological efficacy

Compare microbiological efficacy of treatment with colistin vs meropenen in VAP. The putative pathogen is eliminated from repeated culture of lower respiratory tract.

Time frame: 28 days

Number of participants with adverse events as a measure of safety and tolerability

The evaluation of security will be carried out through collection of adverse events that occur during the trial

Time frame: 28 days

Data from ClinicalTrials.gov

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University Hospital of Alexandroupolis, Medical School University of Thrace

Alexandroupoli, Greece

Evagelismos Hospital, Medical School University of Athens

Athens, Greece

General Hospital of Larissa, Thessalia University

Athens, Greece

Sotiria Hospital, Medical School University of Athens

Athens, Greece

University Hospital Ag. Anargiri, Nurshing School University of Athens

Athens, Greece

University Hospital ATTIKON, Medical School University of Athens

Athens, Greece

University Hospital of Larissa, Medical School University of Athens

Athens, Greece

University Hospital of Heraklion, Medical School University of Crete

Crete, Greece

University Hospital of Ioannina, Medical School, University of Ipirus

Ioannina, Greece

Papanikolaou Hospital,

Thessaloniki, Greece

...and 23 more locations