Trial of Colistin Versus Meropenem in Ventilator-associated Pneumonia (VAP) (CR-GNB)
- Conditions
- Ventilator-associated Bacterial Pneumonia
- Interventions
- Registration Number
- NCT01292031
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 232
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Colistin Colistin Colistin 4.5 MU/iv.plus Colistin 3 MU/iv./8 h. 30 minutes infusion Meropenem Meropenem Meropenem 2 g/iv/ 8 h. 30 minutes infusion
- Primary Outcome Measures
Name Time Method Number of patients who die as a measure of efficacy 28 days 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
Name Time Method Number of patients with clinical healing as a measure of efficacy 28 days 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 28 days 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 28 days The evaluation of security will be carried out through collection of adverse events that occur during the trial
Trial Locations
- Locations (33)
Sotiria Hospital, Medical School University of Athens
🇬🇷Athens, Greece
General Hospital of Larissa, Thessalia University
🇬🇷Athens, Greece
AO Ospedale Niguarda Ca Granda Milano
🇮🇹Milan, Italy
Azienda OspedalieraSant'Andrea
🇮🇹Roma, Rome, Italy
University of Napoli Federico II
🇮🇹Napoli, Italy
Policlinico Universitario A. Gemelli
🇮🇹Roma, Italy
S.Giovanni Battista Molinette Hospital Turin
🇮🇹Turin, Italy
Complexo Hospitalario A Coruña
🇪🇸A Coruña, Spain
Hospital General de Ciudad Real
🇪🇸Ciudad Real, Spain
Hospital General Universitario Santa Lucía
🇪🇸Cartagena, Spain
University Hospital Reina Sofía
🇪🇸Córdoba, Spain
Hospital Puerta del Mar Universidad de Cádiz
🇪🇸Cádiz, Spain
University Hospital Juan Ramón Jiménez
🇪🇸Huelva, Spain
Hospital de Jerez
🇪🇸Jerez de la Frontera, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital Virgen del Rocío Sevilla
🇪🇸Seville, Spain
Hospital Carlos Haya Universidad de Málaga
🇪🇸Málaga, Spain
Complexo Hospitalario de Orense
🇪🇸Orense, Spain
Hospital Marqués de Valdecillas
🇪🇸Santander, Spain
Hospital Mutua de Terrassa
🇪🇸Tarrasa, Spain
La Fe Universidad de Valencia
🇪🇸Valencia, Spain
Hospital Dr. Peset
🇪🇸Valencia, Spain
University Hospital of Larissa, Medical School University of Athens
🇬🇷Athens, Greece
University Hospital of Ioannina, Medical School, University of Ipirus
🇬🇷Ioannina, Greece
University Hospital Ag. Anargiri, Nurshing School University of Athens
🇬🇷Athens, Greece
University Hospital of Heraklion, Medical School University of Crete
🇬🇷Crete, Greece
Papanikolaou Hospital,
🇬🇷Thessaloniki, Greece
Evagelismos Hospital, Medical School University of Athens
🇬🇷Athens, Greece
University Hospital of Alexandroupolis, Medical School University of Thrace
🇬🇷Alexandroupolis, Greece
University Hospital ATTIKON, Medical School University of Athens
🇬🇷Athens, Greece
AOU Cisanello- Pisa
🇮🇹Pisa, Italy