Trial of Colistin Versus Meropenem in Ventilator-associated Pneumonia (VAP) (CR-GNB) (MagicBullet)
This study is currently recruiting participants.
Verified March 2013 by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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: March 4, 2013
Last verified: March 2013
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Purpose
- 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.
- To compare the safety of treatment with colistin vs meropenem in VAP.
- 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 2013 |
| Estimated Primary Completion Date: | June 2013 (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
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 | Not yet recruiting |
| Alexandroupolis, Greece | |
| Principal Investigator: Ioannis Pneumatikos, PhD | |
| University Hospital of Larissa, Medical School University of Athens | Not yet recruiting |
| Athens, Greece | |
| Principal Investigator: Epaminondas Zakynthinos, PhD | |
| Sotiria Hospital, Medical School University of Athens | Not yet recruiting |
| Athens, Greece | |
| Principal Investigator: Antonio Koutsoukou, PhD | |
| University Hospital Ag. Anargiri, Nurshing School University of Athens | Not yet recruiting |
| Athens, Greece | |
| Principal Investigator: George Baltopoulos, PhD | |
| Evagelismos Hospital, Medical School University of Athens | Not yet recruiting |
| Athens, Greece | |
| Principal Investigator: Spiros Zakinthinos, PhD | |
| University Hospital ATTIKON, Medical School University of Athens | Not yet recruiting |
| Athens, Greece | |
| Principal Investigator: Apostolos Armaganidis, PhD | |
| General Hospital of Larissa, Thessalia University | Not yet recruiting |
| Athens, Greece | |
| Principal Investigator: Apostolos Komnos, PhD | |
| University Hospital of Heraklion, Medical School University of Crete | Not yet recruiting |
| Crete, Greece | |
| Principal Investigator: Dimitrios Georgopoulos, PhD | |
| University Hospital of Ioannina, Medical School, University of Ipirus | Not yet recruiting |
| Ioannina, Greece | |
| Principal Investigator: George Nakos, PhD | |
| Papanikolaou Hospital, | Not yet recruiting |
| Thessaloniki, Greece | |
| Principal Investigator: Militsa Bitsani, PhD | |
| Italy | |
| AO Ospedale Niguarda Ca Granda Milano | Not yet recruiting |
| Milan, Italy | |
| Principal Investigator: Andrea De Gasperi, PhD | |
| University of Napoli Federico II | Not yet recruiting |
| Napoli, Italy | |
| Principal Investigator: Edoardo De Robertis-Rosalba, PhD | |
| Policlinico Umberto I Università La Sapienza | Not yet recruiting |
| Roma, Italy | |
| Principal Investigator: Monica Rocco, PhD | |
| Policlinico Universitario A. Gemelli | Recruiting |
| Roma, Italy | |
| Principal Investigator: Mariano Pennisi, PhD | |
| S.Giovanni Battista Molinette Hospital Turin | Not yet 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 | |
| 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 | |
| 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 | |
| La Fe Universidad de Valencia | Recruiting |
| Valencia, Spain, 46009 | |
| Principal Investigator: Juan Bonastre Mora, PhD | |
| Hospital Dr. Peset | Recruiting |
| Valencia, Spain, 46017 | |
| Principal Investigator: Rafael Zaragoza Crespo | |
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: | March 4, 2013 |
| 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, Bacterial Pneumonia Pneumonia, Ventilator-Associated Bacterial Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Cross Infection Infection |
Ventilator-Induced Lung Injury Lung Injury Colistin Meropenem Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013