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NCT00920270 Clinical Trial

Nebulized Colistin for Hospital-Acquired Pneumonia

Pneumonia Clinical Trial

Official title:
Efficacy and Safety of Nebulized Colistin for Adjunctive Therapy of Hospital-Acquired Pneumonia Caused by Gram Negative Bacteria

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT00920270
Other study ID # Siriraj CEU 50-002
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received June 11, 2009
Last updated June 11, 2009
Start date June 2006

Study information
Verified date June 2006
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 140
Est. completion date
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• nebulized colistin
nebulized colistin 75 mg every 12 hours
• antibiotics
conventional parenteral antibiotics

Locations
Country Name City State
Thailand Siriraj Hospital Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical response 14 days after Treatment No
Secondary Microbiological response and safety 14 days after treatment Yes
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