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

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ClinicalTrials.gov Identifier: NCT00300560
Recruitment Status : Unknown
Verified March 2006 by Mahidol University.
Recruitment status was:  Recruiting
First Posted : March 9, 2006
Last Update Posted : May 22, 2006
Sponsor:
Information provided by:
Mahidol University

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

Condition or disease Intervention/treatment Phase
Infections Drug: Colistin Phase 3

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 Type : Interventional  (Clinical Trial)
Enrollment : 152 participants
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
Study Start Date : February 2006
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources




Primary Outcome Measures :
  1. Clinical response

Secondary Outcome Measures :
  1. Microbiological response


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

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

ClinicalTrials.gov Identifier: NCT00300560     History of Changes
Other Study ID Numbers: SirirajCEU49-004
First Posted: March 9, 2006    Key Record Dates
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