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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Collaborator: European Commission
• Treatments: Colistin; Meropenem; Thienamycins

Criteria

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.