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

Tracking Information

First Received Date ^ICMJE

March 7, 2006

Last Updated Date

May 19, 2006

Start Date ^ICMJE

February 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Clinical response

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00300560 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Microbiological response

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Infections

Intervention ^ICMJE

Drug: Colistin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

152

Completion Date

December 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Visanu Thamlikitkul, MD

662 419 7000 ext 6626

sivth@mahidol.ac.th

Location Countries ^ICMJE

Thailand

Administrative Information

NCT ID ^ICMJE

NCT00300560

Responsible Party

Study ID Numbers ^ICMJE

SirirajCEU49-004

Study Sponsor ^ICMJE

Mahidol University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Visanu Thamlikitkul, MD

Faculty of Medicine Siriraj Hospital

Information Provided By

Mahidol University

Verification Date

March 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP