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

Primary Purpose

Infections

Status

Unknown status

Phase

Phase 3

Locations

Thailand

Study Type

Interventional

Intervention

Colistin

About this trial

This is an interventional treatment trial for Infections focused on measuring ESBL-producing E.coli Infections, ESBL-producing Klebsiella pneumoniae Infections, Colistin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Division of Infectious disease and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj HospitalRecruiting

Outcomes

Primary Outcome Measures

Clinical response

Secondary Outcome Measures

Microbiological response

Full Information

NCT ID

NCT00300560

First Posted

March 7, 2006

Last Updated

May 19, 2006

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT00300560

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2006

Overall Recruitment Status

Unknown status

Study Start Date

February 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Mahidol University

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infections

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

152 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Colistin

Primary Outcome Measure Information:

Title

Clinical response

Secondary Outcome Measure Information:

Title

Microbiological response

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Visanu Thamlikitkul, MD

Phone

662 419 7000

Ext

6626

sivth@mahidol.ac.th

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Visanu Thamlikitkul, MD

Organizational Affiliation

Faculty of Medicine Siriraj Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Division of Infectious disease and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital

City

Bangkoknoi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sunee Thanakhumtorn, RN

Phone

662 4197000

Ext

6616

srstn@mahidol.ac.th

First Name & Middle Initial & Last Name & Degree

Visanu Thamlikitkul, MD

First Name & Middle Initial & Last Name & Degree

Pornpan Koomanachai, MD

First Name & Middle Initial & Last Name & Degree

Hutsaya Tantipong, MD

First Name & Middle Initial & Last Name & Degree

Sriripetcharat Mekviwattanawong, MD

First Name & Middle Initial & Last Name & Degree

Pasri Maharomn, MD

First Name & Middle Initial & Last Name & Degree

Pinyo Rattanaumpawan, MD

12. IPD Sharing Statement

Learn more about this trial

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

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