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

February 2, 2016 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

232

Phase

  • Phase 3

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

  • Greece
      • Alexandroupolis, Greece
        • University Hospital of Alexandroupolis, Medical School University of Thrace
      • Athens, 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
      • Crete, Greece
        • University Hospital of Heraklion, Medical School University of Crete
      • Ioannina, Greece
        • University Hospital of Ioannina, Medical School, University of Ipirus
      • Thessaloniki, Greece
        • Papanikolaou Hospital,
  • Italy
      • Milan, Italy
        • AO Ospedale Niguarda Ca Granda Milano
      • Napoli, Italy
        • University of Napoli Federico II
      • Pisa, Italy
        • AOU Cisanello- Pisa
      • Roma, Italy
        • Policlinico Universitario A. Gemelli
      • Turin, Italy
        • S.Giovanni Battista Molinette Hospital Turin
    • Rome
      • Roma, Rome, Italy
        • Azienda OspedalieraSant'Andrea
  • Spain
      • A Coruña, Spain, 15006
        • Complexo Hospitalario a Coruna
      • Cartagena, Spain
        • Hospital General Universitario Santa Lucia
      • Ciudad Real, Spain
        • Hospital General de Ciudad Real
      • Cádiz, Spain
        • Hospital Puerta del Mar Universidad de Cádiz
      • Córdoba, Spain, 14004
        • University Hospital Reina Sofia
      • Huelva, Spain, 21005
        • University Hospital Juan Ramón Jiménez
      • Jerez de la Frontera, Spain
        • Hospital de Jerez
      • Madrid, Spain
        • Hospital 12 de Octubre
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Málaga, Spain
        • Hospital Universitario Virgen de La Victoria
      • Málaga, Spain
        • Hospital Carlos Haya Universidad de Málaga
      • Orense, Spain
        • Complexo Hospitalario de Orense
      • Santander, Spain
        • Hospital Marqués de Valdecillas
      • Seville, Spain, 41013
        • Hospital Virgen del Rocío Sevilla
      • Tarrasa, Spain, 08221
        • Hospital Mutua De Terrassa
      • Valencia, Spain, 46017
        • Hospital Dr. Peset
      • Valencia, Spain, 46009
        • La Fe Universidad de Valencia

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Colistin
Colistin 4.5 MU/iv.plus Colistin 3 MU/iv./8 h. 30 minutes infusion
Drug: Colistin
Colistin 4.5 MU/iv plus Colistin 3 MU/iv./8 h. 30 minutes infusion
ACTIVE_COMPARATOR: Meropenem
Meropenem 2 g/iv/ 8 h. 30 minutes infusion
Drug: Meropenem
Meropenem 2 g/iv/ 8 h. 30 minutes infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
28 days
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.
28 days
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
28 days

Collaborators and Investigators

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

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Collaborators

European Commission

Investigators

  • Study Chair: José Miguel Cisneros-Herreros, PhD, Andaluz Health Service

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

May 1, 2012

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

February 2, 2011

First Submitted That Met QC Criteria

February 8, 2011

First Posted (ESTIMATE)

February 9, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 3, 2016

Last Update Submitted That Met QC Criteria

February 2, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-023310-31

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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