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

This study is currently recruiting participants.

Verified by Mahidol University, March 2006

Sponsored by:	Mahidol University
Information provided by:	Mahidol University
ClinicalTrials.gov Identifier:	NCT00300560

Purpose

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

Condition	Intervention	Phase
Infections	Drug: Colistin	Phase III

MedlinePlus related topics: Pneumonia

Drug Information available for: Colistin Colistin sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy and Safety of Colistin for Therapy of Infections Caused by Extended Spectrum Beta-Lactamase(ESBL) Producing Klebsiella Pneumoniae or Escherichia Coli

Further study details as provided by Mahidol University:

Primary Outcome Measures:

Clinical response

Secondary Outcome Measures:

Microbiological response

Estimated Enrollment:	152
Study Start Date:	February 2006
Estimated Study Completion Date:	December 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300560

Contacts

Contact: Visanu Thamlikitkul, MD

662 419 7000 ext 6626

sivth@mahidol.ac.th

Locations

Thailand, Bangkok
Division of Infectious disease and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital	Recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Contact: Sunee Thanakhumtorn, RN 662 4197000 ext 6616 srstn@mahidol.ac.th
Principal Investigator: Visanu Thamlikitkul, MD
Sub-Investigator: Pornpan Koomanachai, MD
Sub-Investigator: Hutsaya Tantipong, MD
Sub-Investigator: Sriripetcharat Mekviwattanawong, MD
Sub-Investigator: Pasri Maharomn, MD
Sub-Investigator: Pinyo Rattanaumpawan, MD

Sponsors and Collaborators

Mahidol University

Investigators

Principal Investigator:

Visanu Thamlikitkul, MD

Faculty of Medicine Siriraj Hospital

More Information

Study ID Numbers:	SirirajCEU49-004
Study First Received:	March 7, 2006
Last Updated:	May 19, 2006
ClinicalTrials.gov Identifier:	NCT00300560
Health Authority:	Thailand: Food and Drug Administration

Keywords provided by Mahidol University:

ESBL-producing E.coli Infections
ESBL-producing Klebsiella pneumoniae Infections
Colistin

Study placed in the following topic categories:

Colistin
Klebsiella
Respiratory Tract Infections
Respiratory Tract Diseases

Lung Diseases
Escherichia coli Infections
Klebsiella Infections
Pneumonia

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases

Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009