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NCT00300560 Clinical Trial

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

Infections Clinical Trial

Official title:
Efficacy and Safety of Colistin for Therapy of Infections Caused by Extended Spectrum Beta-Lactamase(ESBL) Producing Klebsiella Pneumoniae or Escherichia Coli

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00300560
Other study ID # SirirajCEU49-004
Secondary ID
Status Recruiting
Phase Phase 3
First received March 7, 2006
Last updated May 19, 2006
Start date February 2006
Est. completion date December 2006

Study information
Verified date March 2006
Source Mahidol University
Contact Visanu Thamlikitkul, MD
Phone 662 419 7000
Email sivth@mahidol.ac.th
Is FDA regulated No
Health authority Thailand: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 152
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Drug:
• Colistin

Locations
Country Name City State
Thailand Division of Infectious disease and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital Bangkoknoi 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
Secondary Microbiological response
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