Trial of Colistin Versus Meropenem in Ventilator-associated Pneumonia (VAP) (CR-GNB)
Trial of Colistin Versus Meropenem in Ventilator-associated Pneumonia (VAP) (CR-GNB)
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
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.
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.