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| Name | Class |
|---|---|
| European Commission | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colistin | Experimental | Colistin 4.5 MU/iv.plus Colistin 3 MU/iv./8 h. 30 minutes infusion |
|
| Meropenem | Active Comparator | Meropenem 2 g/iv/ 8 h. 30 minutes infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colistin | Drug | Colistin 4.5 MU/iv plus Colistin 3 MU/iv./8 h. 30 minutes infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with clinical healing as a measure of efficacy | Demostrate that colistin is not inferior to meropenem in empiric treatment of VAP regarding efficacy: clinical healing in patients clinically evaluated | 28 days |
| Microbiological resolution as a measure of microbiological efficacy |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| José Miguel Cisneros-Herreros, PhD | Andaluz Health Service | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Alexandroupolis, Medical School University of Thrace | Alexandroupoli | Greece | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31779711 | Derived | 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. | |
| 25872790 |
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| Meropenem |
| Drug |
Meropenem 2 g/iv/ 8 h. 30 minutes infusion |
|
Compare microbiological efficacy of treatment with colistin vs meropenen in VAP. The putative pathogen is eliminated from repeated culture of lower respiratory tract. |
| 28 days |
| Number of participants with adverse events as a measure of safety and tolerability | The evaluation of security will be carried out through collection of adverse events that occur during the trial | 28 days |
| 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 | Naples | 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 |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D003091 | Colistin |
| D000077731 | Meropenem |
| ID | Term |
|---|---|
| D011113 | Polymyxins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D023181 | Antimicrobial Cationic Peptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000089882 | Antimicrobial Peptides |
| D052899 | Pore Forming Cytotoxic Proteins |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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