Colistin Versus Colistin Plus Fosfomycin for Infections Caused by MDR Acinetobacter Baumannii

December 24, 2011 updated by: Visanu Thamlikitkul, Mahidol University

Colistin Plus Fosfomycin in Multi-Drug Resistant Acinetobacter Baumannii

In Siriraj Hospital, colistin alone for treatment of MDR A. baumannii contributed to mortality 45% Fosfomycin is an antimicrobial which has activity against gram-negative bacterial including MDR A. baumannii In this study, we compare the clinical and microbiologicalresponse of colistin alone versus colistin plus fosfomycin in treatment of A. baumannii infected patients

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Inclusion criteria

  • Age> 18 years
  • Hospitalized to Siriraj Hospital
  • Infected caused by A. baumannii
  • Need Colistin treatment

Exclusion criteria

  • Pregnancy or Lactating mother
  • Colistin or Fosfomycin Allergy
  • Patients who have severe abnormal renal or liver function

Study Type

Interventional

Enrollment (Anticipated)

92

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 Contact

  • Name: Dr Visanu Thamlikitkul, Professor
  • Phone Number: 662-419-6626
  • Email: sivth@mahidol.ac.th

Study Contact Backup

  • Name: Dr Pornpan Koomanachai, MD
  • Phone Number: 662-419-7783
  • Email: nokmed@yahoo.com

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Siriraj Hospital
        • Contact:
        • Contact:
          • Dr. Pornpan Koomanachai, MD
          • Phone Number: 662-419-7783
          • Email: nokmed@yahoo.com
        • Principal Investigator:
          • Dr. Pornpan Koomanachai, 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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age> 18 years
  • Hospitalized to Siriraj Hospital
  • Infected caused by A. baumannii
  • Need Colistin treatment

Exclusion criteria:

  • Pregnancy or Lactating mother
  • Colistin or Fosfomycin Allergy
  • Patients who have severe abnormal renal or liver function

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: colistin
Colistimethate sodium 2.5-5mg/kg iv
Drug: colistin
Colistimethate sodium 2.5-5mg/kg of colistin base
Other Names:
  • Colistate
Active Comparator: colistin plus fosfomycin
colistimethate sodium 2.5-5mg/kg iv plus fosfomycin 2gm iv every 12 hours
Drug: colistin plus fosfomycin
colitimethate sodium 2.5-5mg/kg iv plus fosfomycin 2gm iv every 12 hours
Other Names:
  • Colistate
  • Fosmicin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of subjects with cure or improvement
Time Frame: up to 28days
cure improvement worse death
up to 28days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of subjects with eradication of causative bacteria
Time Frame: up to 28days
eradication persistence superinfection
up to 28days

Collaborators and Investigators

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

Sponsor

Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2010

Primary Completion (Anticipated)

May 1, 2012

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

February 15, 2011

First Submitted That Met QC Criteria

February 16, 2011

First Posted (Estimate)

February 17, 2011

Study Record Updates

Last Update Posted (Estimate)

December 29, 2011

Last Update Submitted That Met QC Criteria

December 24, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Siriraj CEU53-001

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.

Clinical Trials on Drug Safety

Clinical Trials on colistin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe