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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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: August 5, 2014
Last verified: August 2014
  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


Estimated Enrollment: 400
Study Start Date: May 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: November 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
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

Contacts
Contact: Clara Rosso, MD 0034955013414 claram.rosso.sspa@juntadeandalucia.es
Contact: Monteau Sophie 0034955013645 sophie.monteau.exts@juntadeandalucia.es

Locations
Greece
University Hospital of Alexandroupolis, Medical School University of Thrace Recruiting
Alexandroupolis, Greece
Principal Investigator: Ioannis Pneumatikos, PhD         
General Hospital of Larissa, Thessalia University Recruiting
Athens, Greece
Principal Investigator: Apostolos Komnos, PhD         
University Hospital ATTIKON, Medical School University of Athens Recruiting
Athens, Greece
Principal Investigator: Apostolos Armaganidis, PhD         
Sotiria Hospital, Medical School University of Athens Recruiting
Athens, Greece
Principal Investigator: Antonio Koutsoukou, PhD         
University Hospital Ag. Anargiri, Nurshing School University of Athens Recruiting
Athens, Greece
Principal Investigator: George Baltopoulos, PhD         
Evagelismos Hospital, Medical School University of Athens Recruiting
Athens, Greece
Principal Investigator: Spiros Zakinthinos, PhD         
University Hospital of Larissa, Medical School University of Athens Recruiting
Athens, Greece
Principal Investigator: Epaminondas Zakynthinos, PhD         
University Hospital of Heraklion, Medical School University of Crete Recruiting
Crete, Greece
Principal Investigator: Dimitrios Georgopoulos, PhD         
University Hospital of Ioannina, Medical School, University of Ipirus Recruiting
Ioannina, Greece
Principal Investigator: George Nakos, PhD         
Papanikolaou Hospital, Recruiting
Thessaloniki, Greece
Principal Investigator: Militsa Bitsani, PhD         
Italy
Azienda OspedalieraSant'Andrea Not yet recruiting
Roma, Rome, Italy
Principal Investigator: Roberto de Blasi, PhD         
AO Ospedale Niguarda Ca Granda Milano Not yet recruiting
Milan, Italy
Principal Investigator: Andrea De Gasperi, PhD         
University of Napoli Federico II Recruiting
Napoli, Italy
Principal Investigator: Edoardo De Robertis-Rosalba, PhD         
AOU Cisanello- Pisa Not yet recruiting
Pisa, Italy
Contact: D Guarracino, MD         
Principal Investigator: D Guarracino, MD         
Policlinico Universitario A. Gemelli Recruiting
Roma, Italy
Principal Investigator: Mariano Pennisi, PhD         
S.Giovanni Battista Molinette Hospital Turin Recruiting
Turin, Italy
Principal Investigator: V. Marco Ranieri-Francesco de Rosa, PhD         
Spain
Complexo Hospitalario A Coruña Recruiting
A Coruña, Spain, 15006
Principal Investigator: Luis Alvarez-Rocha, PhD         
Hospital General Universitario Santa Lucía Recruiting
Cartagena, Spain
Principal Investigator: José Miguel Allegue, PhD         
Hospital General de Ciudad Real Recruiting
Ciudad Real, Spain
Principal Investigator: Mª Luisa Gómez Grande, PhD         
Hospital Puerta del Mar Universidad de Cádiz Recruiting
Cádiz, Spain
Principal Investigator: Rafael Sierra Camerino, PhD         
University Hospital Reina Sofía Recruiting
Córdoba, Spain, 14004
Contact: Juan Carlos Pozo, MD.PhD       drjcpozo@hotmail.com   
Principal Investigator: Juan Carlos Pozo, MD.PhD         
University Hospital Juan Ramón Jiménez Recruiting
Huelva, Spain, 21005
Contact: Pedro Dominguez García, MD. PhD       pjdg_ico@hotmail.com   
Principal Investigator: Pedro Dominguez García, MD.PhD         
Hospital de Jerez Recruiting
Jerez de la Frontera, Spain
Principal Investigator: Angel Estella García, PhD         
Hospital Clínico San Carlos Recruiting
Madrid, Spain
Principal Investigator: Miguel Sánchez García, PhD         
Hospital 12 de Octubre Recruiting
Madrid, Spain
Principal Investigator: Juan Carlos Montejo González, PhD         
Hospital Universitario Virgen de la Victoria Recruiting
Málaga, Spain
Principal Investigator: Mª Victoria Torre Prados, PhD         
Hospital Carlos Haya Universidad de Málaga Recruiting
Málaga, Spain
Principal Investigator: Manuel Herrera Gutiérrez, PhD         
Complexo Hospitalario de Orense Recruiting
Orense, Spain
Principal Investigator: Pablo Vidal Cortés, MD         
Hospital Marqués de Valdecillas Recruiting
Santander, Spain
Principal Investigator: Alvaro Castellanos, PhD         
Hospital Virgen del Rocío Sevilla Recruiting
Seville, Spain, 41013
Principal Investigator: José Garnacho Montero, PhD         
Hospital Mutua de Terrassa Recruiting
Tarrasa, Spain, 08221
Principal Investigator: Ricard Ferrer, PhD         
Hospital Dr. Peset Recruiting
Valencia, Spain, 46017
Principal Investigator: Rafael Zaragoza Crespo         
La Fe Universidad de Valencia Recruiting
Valencia, Spain, 46009
Principal Investigator: Juan Bonastre Mora, PhD         
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:
No publications provided

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: August 5, 2014
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, Bacterial
Pneumonia, Ventilator-Associated
Bacterial Infections
Cross Infection
Infection
Lung Diseases
Lung Injury
Respiratory Tract Diseases
Respiratory Tract Infections
Ventilator-Induced Lung Injury
Colistin
Meropenem
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014