Ventilator-associated Bacterial Pneumonia
Conditions
Keywords
VAP, MDR-GNB, colistin, meropenem
Brief 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.
Interventions
DRUGColistin
Colistin 4.5 MU/iv plus Colistin 3 MU/iv./8 h. 30 minutes infusion
DRUGMeropenem
Meropenem 2 g/iv/ 8 h. 30 minutes infusion
Sponsors
European Commission
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients who die as a measure of efficacy | 28 days | Demostrate that colistin iv. is not inferior to meropenen in empiric treatment of VAP regarding the final point of primary efficacy: mortality in the 28 subsequent days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with clinical healing as a measure of efficacy | 28 days | Demostrate that colistin is not inferior to meropenem in empiric treatment of VAP regarding efficacy: clinical healing in patients clinically evaluated |
| Microbiological resolution as a measure of microbiological efficacy | 28 days | Compare microbiological efficacy of treatment with colistin vs meropenen in VAP. The putative pathogen is eliminated from repeated culture of lower respiratory tract. |
| Number of participants with adverse events as a measure of safety and tolerability | 28 days | The evaluation of security will be carried out through collection of adverse events that occur during the trial |
Countries
Greece, Italy, Spain
Outcome results
None listed