drugset / Trial / NCT01292031
Trial of Colistin Versus Meropenem in Ventilator-associated Pneumonia (VAP) (CR-GNB)
Phase 3
Completed
232 enrolled
Andalusian Public Foundation for Health Research in Seville
European Commission · collab
RandomizedSingle-groupOpen-labelTreatment
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
Timeline
- Start
- 2012-05
- Primary completion
- 2015-12
- Completion
- 2015-12
Publications
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Colistin | Other / unclassified | 3e+06 iu | Intravenous |
| Comparator | Meropenem | Small molecule | 2 g | Intravenous |