MedTrace Logo

Effect of Aerosolised Colistin in Ventilator Associated Pneumonia

NCT02683603 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2016-02-17

No results posted yet for this study

Summary

the management of Ventilator-associated pneumonia (VAP) caused by multidrug-resistant (MDR) gram-negative bacilli (GNB) represent a real therapeutic dilemma in intensive care unit (ICU). Colistin remains an effective agent against MDR GNB. However, because of its side effects, mainly nephrotoxicity, other modalities than the intra venous (IV) route should be tried. Several recent data emphasize the interest of inhaled route. The investigators purpose was to evaluate the effectiveness and systemic toxicity of aerosolized colistin in ventilator associated pneumonia.

Conditions

  • Pneumonia, Ventilator-Associated

Interventions

DRUG

AS colistin and "imipenem"

colimycin (colistin) powder (1 million units (MU) by flakon) by AS route in addition to imipenem

DRUG

IV colistin " and "imipenem" .

colimycin (colistin) powder (1 MU by flakon) by intravenous route in addition to imipenem

DRUG

AS colimycin (colistin)

nebulisation of colimycin (colistin) for 30 minutes 3 times per day during at least 14 days. Nebulisation was made via an ultrasonic vibrating plates nebulizer (Aeroneb Pro® Aerogen Nektar Corporation, Galway, Ireland).

DRUG

IV colimycin (colistin)

intravenous colimycin (colistin) : 9 MU during 60 minutes followed by 4.5 million units 2 times per day

DRUG

AS colistin and imipenem

IV imipenem 1 g three times per day.

DRUG

IV colistin and imipenem

IV imipenem 1 g three times per day

Sponsors & Collaborators

  • Tunis University

    lead OTHER

Principal Investigators

  • Ahlem Trifi · Tunis University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • Tunisia

Study Locations

More Related Trials

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 NCT02683603 on ClinicalTrials.gov