Nebulized Colistin for Hospital-Acquired Pneumonia

Phase 3

• Conditions: Pneumonia
• Interventions: Drug: antibiotics; Drug: nebulized colistin

• Registration Number: NCT00920270
• Lead Sponsor: Mahidol University

Brief Summary

Nebulized Colistin for Adjunctive Therapy of Hospital-Acquired Pneumonia caused by Gram Negative Bacteria should be more effective than conventional therapy

Detailed Description

Randomized Controlled Clinical Trial in hospitalized adult patients with hospital-acquired pneumonia. The patients are allocated to conventional group or nebulized colistin group. The conventional group receives conventional antibiotics whereas the nebulized colistin group receives nebulized colistin in addition to conventional antibiotics. The outcomes are clinical response and microbiological responses.

Study Timeline

• Status Verified: 2006-06
• Study Start: 2006-06
• Study First Submitted: 2009-06-11
• Study First Submitted QC: 2009-06-11
• Last Update Submitted: 2009-06-11
• Study First Posted: 2009-06-15
• Last Update Posted: 2009-06-15
• Primary Completion: 2010-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Adult (age>18 years) hospitalized patient with hospital-acquired pneumonia due to Gram negative bacteria

Exclusion Criteria

• pregnancy
• lactating woman
• colistin allergy
• severe renal impairment
• epilepsy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
antibiotic	antibiotics	conventional antibiotics
colistin group	nebulized colistin	nebulized colistin

Primary Outcome Measures

Name	Time	Method
Clinical response	14 days after Treatment

Secondary Outcome Measures

Name	Time	Method
Microbiological response and safety	14 days after treatment

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkok, Thailand