Efficacy and Safety of Colistin for Therapy of Infections Caused by ESBL Producing K.Pneumoniae or E.Coli

Phase 3

• Conditions: Infections

• Registration Number: NCT00300560
• Lead Sponsor: Mahidol University

Brief Summary

In patients with documented ESBL-producing E.coli and Klebsiella pneumoniae will be allocated to receive colistin or conventional antibiotic regimen.

Detailed Description

In patients with documented ESBL-producing E.coli and Klebsiella pneumoniae will be allocated to receive colistin or conventional antibiotic regimen.The primary outcome is clinical response and secondary outcomes are microbiological response and adverse events.

Study Timeline

• Study Start: 2006-02
• Status Verified: 2006-03
• Study First Submitted: 2006-03-07
• Study First Submitted QC: 2006-03-08
• Study First Posted: 2006-03-09
• Last Update Submitted: 2006-05-19
• Last Update Posted: 2006-05-22
• Study Completion: 2006-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

• Age > 18 yr.
• Hospitalized to Siriraj Hospital
• Infections with ESBL-producing E.coli or K.pneumoniae
• Consent informed consent

Exclusion Criteria

• Pregnancy or lactating mother
• Colistin allergy
• Neurologic diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical response

Secondary Outcome Measures

Name	Time	Method
Microbiological response

Trial Locations

Locations (1)

Division of Infectious disease and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkoknoi, Bangkok, Thailand