Trial of Colistin Versus Meropenem in Ventilator-associated Pneumonia (VAP) (CR-GNB)
NCT ID: NCT01292031
Last Updated: 2016-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
232 participants
INTERVENTIONAL
2012-05-31
2015-12-31
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Colistin
Colistin 4.5 MU/iv.plus Colistin 3 MU/iv./8 h. 30 minutes infusion
Colistin
Colistin 4.5 MU/iv plus Colistin 3 MU/iv./8 h. 30 minutes infusion
Meropenem
Meropenem 2 g/iv/ 8 h. 30 minutes infusion
Meropenem
Meropenem 2 g/iv/ 8 h. 30 minutes infusion
Interventions
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Colistin
Colistin 4.5 MU/iv plus Colistin 3 MU/iv./8 h. 30 minutes infusion
Meropenem
Meropenem 2 g/iv/ 8 h. 30 minutes infusion
Eligibility Criteria
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Inclusion Criteria
The patient or his/her legal representative must sign a document of informed consent approved by the Ethics Review Committee.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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European Commission
OTHER
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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Principal Investigators
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José Miguel Cisneros-Herreros, PhD
Role: STUDY_CHAIR
Andaluz Health Service
Locations
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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, Spain
University Hospital Juan Ramón Jiménez
Huelva, Huelva, Spain
Complexo Hospitalario A Coruña
A Coruña, , 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, , Spain
Hospital Mutua de Terrassa
Tarrasa, , Spain
La Fe Universidad de Valencia
Valencia, , Spain
Hospital Dr. Peset
Valencia, , Spain
Countries
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References
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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.
Rosso-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.
Other Identifiers
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2010-023310-31
Identifier Type: -
Identifier Source: org_study_id
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