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

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status and phase

Completed

Phase 3

Conditions

Ventilator-associated Bacterial Pneumonia

Treatments

Drug: Colistin

Drug: Meropenem

Study type

Interventional

Funder types

Other

Identifiers

NCT01292031

2010-023310-31

Details and patient eligibility

About

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.
To compare the safety of treatment with colistin vs meropenem in VAP.
To compare microbiological efficacy of treatment with colistin vs meropenem in VAP

Full 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.

Enrollment

232 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.