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Nebulized and Intravenous Colistin in Ventilator Associated-pneumonia

NCT02906722 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2018-08-13

No results posted yet for this study

Summary

Few antimicrobials are available to treat ventilated associated pneumonia (VAP) caused by Gram negative multi-resistant (MDR) bacteria. Colimycin often remains the only active antibiotic. The aim of the study is to demonstrate the superiority of nebulized colimycin over intravenous colimycin to treat VAP caused by Gramnegative MDR bacteria.

Conditions

  • Ventilator-associated Pneumonia

Interventions

DRUG

Intravenous colimycin

administration once, twice or 3 times per day according to renal function

DRUG

Intravenous placebo

administration once, twice or 3 times per day according to renal function

DRUG

Nebulized colimycin

Nebulization is performed with a vibrating plate nebulizer (Aeroneb® Solo) every 8h

DRUG

Nebulized placebo

Nebulization is performed with a vibrating plate nebulizer (Aeroneb® Solo) every 8h

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Qin LU, MD, PhD · Assistance Publique Hoptiaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2018-03-27
Completion
2018-06-19

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02906722 on ClinicalTrials.gov