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

This study has been completed.
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier:
NCT01292031
First received: February 2, 2011
Last updated: February 2, 2016
Last verified: February 2016
  Purpose
  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

Condition Intervention Phase
Ventilator-associated Bacterial Pneumonia
Drug: Colistin
Drug: Meropenem
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Open Label, Multicenter, Non-inferiority Trial to Compare Safety and Efficacy of Colistin vs. Meropenem in VAP Caused by CR-GNB

Resource links provided by NLM:


Further study details as provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:

Primary Outcome Measures:
  • Number of patients who die as a measure of efficacy [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Number of patients with clinical healing as a measure of efficacy [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Demostrate that colistin is not inferior to meropenem in empiric treatment of VAP regarding efficacy: clinical healing in patients clinically evaluated

  • Microbiological resolution as a measure of microbiological efficacy [ Time Frame: 28 days ] [ Designated as safety issue: No ]

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

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


  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    The evaluation of security will be carried out through collection of adverse events that occur during the trial


Enrollment: 232
Study Start Date: May 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01292031

Locations
Greece
University Hospital of Alexandroupolis, Medical School University of Thrace
Alexandroupolis, 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
Italy
Azienda OspedalieraSant'Andrea
Roma, Rome, Italy
AO Ospedale Niguarda Ca Granda Milano
Milan, Italy
University of Napoli Federico II
Napoli, Italy
AOU Cisanello- Pisa
Pisa, Italy
Policlinico Universitario A. Gemelli
Roma, Italy
S.Giovanni Battista Molinette Hospital Turin
Turin, Italy
Spain
Complexo Hospitalario A Coruña
A Coruña, Spain, 15006
Hospital General Universitario Santa Lucía
Cartagena, Spain
Hospital General de Ciudad Real
Ciudad Real, Spain
Hospital Puerta del Mar Universidad de Cádiz
Cádiz, Spain
University Hospital Reina Sofía
Córdoba, Spain, 14004
University Hospital Juan Ramón Jiménez
Huelva, Spain, 21005
Hospital de Jerez
Jerez de la Frontera, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Carlos Haya Universidad de Málaga
Málaga, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Complexo Hospitalario de Orense
Orense, Spain
Hospital Marqués de Valdecillas
Santander, Spain
Hospital Virgen del Rocío Sevilla
Seville, Spain, 41013
Hospital Mutua de Terrassa
Tarrasa, Spain, 08221
La Fe Universidad de Valencia
Valencia, Spain, 46009
Hospital Dr. Peset
Valencia, Spain, 46017
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
European Commission
Investigators
Study Chair: José Miguel Cisneros-Herreros, PhD Andaluz Health Service
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT01292031     History of Changes
Other Study ID Numbers: 2010-023310-31 
Study First Received: February 2, 2011
Last Updated: February 2, 2016
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
VAP
MDR-GNB
colistin
meropenem

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Pneumonia, Bacterial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
Bacterial Infections
Meropenem
Thienamycins
Colistin
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 28, 2016