Trial of Colistin Versus Meropenem in Ventilator-associated Pneumonia (VAP) (CR-GNB)
MagicBullet
Randomized, Open Label, Multicenter, Non-inferiority Trial to Compare Safety and Efficacy of Colistin vs. Meropenem in VAP Caused by CR-GNB
1 other identifier
interventional
232
3 countries
33
Brief Summary
- 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2012
Typical duration for phase_3
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2011
CompletedFirst Posted
Study publicly available on registry
February 9, 2011
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 3, 2016
February 1, 2016
3.6 years
February 2, 2011
February 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients who die as a measure of efficacy
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 Outcomes (3)
Number of patients with clinical healing as a measure of efficacy
28 days
Microbiological resolution as a measure of microbiological efficacy
28 days
Number of participants with adverse events as a measure of safety and tolerability
28 days
Study Arms (2)
Colistin
EXPERIMENTALColistin 4.5 MU/iv.plus Colistin 3 MU/iv./8 h. 30 minutes infusion
Meropenem
ACTIVE COMPARATORMeropenem 2 g/iv/ 8 h. 30 minutes infusion
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
University Hospital of Alexandroupolis, Medical School University of Thrace
Alexandroupoli, 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
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
University Hospital Reina Sofía
Córdoba, Córdoba, 14004, Spain
University Hospital Juan Ramón Jiménez
Huelva, Huelva, 21005, Spain
Complexo Hospitalario A Coruña
A Coruña, 15006, Spain
Hospital Puerta del Mar Universidad de Cádiz
Cadiz, Spain
Hospital General Universitario Santa Lucía
Cartagena, Spain
Hospital General de Ciudad Real
Ciudad Real, Spain
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
Ourense, Spain
Hospital Marqués de Valdecillas
Santander, Spain
Hospital Virgen del Rocío Sevilla
Seville, 41013, Spain
Hospital Mutua de Terrassa
Tarrasa, 08221, Spain
La Fe Universidad de Valencia
Valencia, 46009, Spain
Hospital Dr. Peset
Valencia, 46017, Spain
Related Publications (2)
Cisneros JM, Rosso-Fernandez CM, Roca-Oporto C, De Pascale G, Jimenez-Jorge S, Fernandez-Hinojosa E, Matthaiou DK, Ramirez P, Diaz-Miguel RO, Estella A, Antonelli M, Dimopoulos G, Garnacho-Montero J; Magic Bullet Working Group WP1. Colistin versus meropenem in the empirical treatment of ventilator-associated pneumonia (Magic Bullet study): an investigator-driven, open-label, randomized, noninferiority controlled trial. Crit Care. 2019 Nov 28;23(1):383. doi: 10.1186/s13054-019-2627-y.
PMID: 31779711DERIVEDRosso-Fernandez C, Garnacho-Montero J, Antonelli M, Dimopoulos G, Cisneros JM; MagicBullet study group. Safety and efficacy of colistin versus meropenem in the empirical treatment of ventilator-associated pneumonia as part of a macro-project funded by the Seventh Framework Program of the European Commission studying off-patent antibiotics: study protocol for a randomized controlled trial. Trials. 2015 Mar 20;16:102. doi: 10.1186/s13063-015-0614-4.
PMID: 25872790DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
José Miguel Cisneros-Herreros, PhD
Andaluz Health Service
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2011
First Posted
February 9, 2011
Study Start
May 1, 2012
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
February 3, 2016
Record last verified: 2016-02