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 because the information has not been verified recently.
Verified March 2006 by Mahidol University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00300560
First received: March 7, 2006
Last updated: May 19, 2006
Last verified: March 2006
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

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
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

No publications provided

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

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

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Colistin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014