Ventilator-associated Bacterial Pneumonia Clinical Trial
Official title:
Randomized, Open Label, Multicenter, Non-inferiority Trial to Compare Safety and Efficacy of Colistin vs. Meropenem in VAP Caused by 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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