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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2006 by Mahidol University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00300560
First Posted: March 9, 2006
Last Update Posted: May 22, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mahidol University
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Colistin for Therapy of Infections Caused by Extended Spectrum Beta-Lactamase(ESBL) Producing Klebsiella Pneumoniae or Escherichia Coli

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00300560


Contacts
Contact: Visanu Thamlikitkul, MD 662 419 7000 ext 6626 sivth@mahidol.ac.th

Locations
Thailand
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

ClinicalTrials.gov Identifier: NCT00300560     History of Changes
Other Study ID Numbers: SirirajCEU49-004
First Submitted: March 7, 2006
First Posted: March 9, 2006
Last Update Posted: May 22, 2006
Last Verified: March 2006

Keywords provided by Mahidol University:
ESBL-producing E.coli Infections
ESBL-producing Klebsiella pneumoniae Infections
Colistin

Additional relevant MeSH terms:
Infection
Communicable Diseases
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Colistin
Anti-Bacterial Agents
Anti-Infective Agents