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

May 19, 2006 updated by: Mahidol University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment

152

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Recruiting
        • Division of Infectious disease and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital
        • Principal Investigator:
          • Visanu Thamlikitkul, MD
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical response

Secondary Outcome Measures

Outcome Measure
Microbiological response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion

December 1, 2006

Study Registration Dates

First Submitted

March 7, 2006

First Submitted That Met QC Criteria

March 8, 2006

First Posted (Estimate)

March 9, 2006

Study Record Updates

Last Update Posted (Estimate)

May 22, 2006

Last Update Submitted That Met QC Criteria

May 19, 2006

Last Verified

March 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SirirajCEU49-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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