Colistin Plus Rifampicin in MDR P. Aeruginosa and A. Baumanii

Drug Safety Clinical Trial

Official title:

Randomized Controlled Trial of Colistin Versus Colistin Plus Rifampicin in MDR P.Aeruginosa and A.Baumanii

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01297855
• Other study ID #: SirirajCEU51-001
• Status: Recruiting
• Phase: Phase 3
• First received: July 20, 2009
• Last updated: December 29, 2011
• Start date: June 2010
• Est. completion date: August 2012

Study information

• Verified date: December 2011
• Source: Mahidol University
• Contact: Visanu Thamlikitkul, Professor
• Phone: 662 419 7000
• Email: sivth[@]mahidol.ac.th
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

In Siriraj Hospital, Colistin alone for treatment of MDR. A.baumanii or P.aeruginosa contributed to mortality 45%. In vitro studies revealed synergism of Rifampicin and Colistin.

In this study, patients with documented MDR. P.aeruginosa or A.baumanii will be allocated to receive Colistin alone and another group will receive Colistin plus Rifampicin.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: August 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age>18 years

• Hospitalized to Siriraj Hospital

• Infection with MDR A.baumanii or P.aeruginosa

• Nescessary for treatment with Colistin

• Patient agrees to participate by giving written informed consent.

Exclusion Criteria:

• pregnancy or lactating mother

• Colistin or Rifampicin allergy

• Active hepatic disease or abnormal liver function test

• patient who suspected infection with mycobacterium tuberculosis

• patient who can not drug by enteral feeding

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Safety

Intervention

Drug:
• Colistin
Colistimethate Sodium dose 2.5-5mg/kg/day
• Colistin plus Rifampicin
Colistin 2.5 to 5 mg/ Kg/ day Rifampin 10 mg/ Kg/ day

Locations

Country	Name	City	State
Thailand	Division of Infectious disease and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of subjects with cure or improvement	Cure Improvement Worse Death	up to day 28	Yes
Secondary	number of subjects with eradication of causative bacteria	Eradication Persistence Superinfection	up to day 28	Yes