NCT01292031

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

Randomized, Open Label, Multicenter, Non-inferiority Trial to Compare Safety and Efficacy of Colistin vs. Meropenem in VAP Caused by CR-GNB

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 232 (actual)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ventilator-associated Bacterial Pneumonia

Interventions

Type	Name	Description
DRUG	Colistin	Colistin 4.5 MU/iv plus Colistin 3 MU/iv./8 h. 30 minutes infusion
DRUG	Meropenem	Meropenem 2 g/iv/ 8 h. 30 minutes infusion

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2011-02-09
• Last updated: 2016-02-03

Locations

33 sites across 3 countries: Greece, Italy, Spain