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Completed

NCT Number: NCT01292031

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

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

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Key information

Conditions

Ventilator-associated Bacterial Pneumonia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital of Alexandroupolis, Medical School University of Thrace, Alexandroupoli, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Colistin

Drug

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

Meropenem

Drug

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

Primary outcomes

  1. Number of patients who die as a measure of efficacy

    Time frame: 28 days

    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

Secondary outcomes

  1. Number of patients with clinical healing as a measure of efficacy

    Time frame: 28 days

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

  2. Microbiological resolution as a measure of microbiological efficacy

    Time frame: 28 days

    Compare microbiological efficacy of treatment with colistin vs meropenen in VAP.

    The putative pathogen is eliminated from repeated culture of lower respiratory tract.

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

    Time frame: 28 days

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

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Collaborators

  • European Commission

Registry information

Official study title

Randomized, Open Label, Multicenter, Non-inferiority Trial to Compare Safety and Efficacy of Colistin vs. Meropenem in VAP Caused by CR-GNB

Acronym: MagicBullet

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 9, 2011
Registry last updated
Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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