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

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

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.

Study Overview

• Status: Unknown
• Conditions: Drug Safety
• Intervention / Treatment: Drug: Colistin; Drug: Colistin plus Rifampicin

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Visanu Thamlikitkul, Professor; Phone Number: 6626 662 419 7000; Email: sivth@mahidol.ac.th
• Study Contact Backup: Name: Sunee Thanakhumtorn; Phone Number: 6616 662 419 7000; Email: srstn@mahidol.ac.th

Study Locations

• Thailand
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Recruiting
      • Division of Infectious disease and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital
      • Contact: Visanu Thamlikitkul, Professor; Phone Number: 6626 662 419 7000; Email: sivth@mahidol.ac.th
      • Contact: Sunee Thanakhumtorn; Phone Number: 6616 662 419 7000; Email: srstn@mahidol.ac.th
      • Principal Investigator: Sukij Piyasirisilp, MD

Participation Criteria

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 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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Colistin; Colistate	Drug: Colistin; Colistimethate Sodium dose 2.5-5mg/kg/day; Other Names: Colistate
Experimental: Colistin plus Rifampicin; Colistate Rifampin	Drug: Colistin plus Rifampicin; Colistin 2.5 to 5 mg/ Kg/ day Rifampin 10 mg/ Kg/ day; Other Names: Rifampin; Colistate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of subjects with cure or improvement	Cure Improvement Worse Death	up to day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of subjects with eradication of causative bacteria	Eradication Persistence Superinfection	up to day 28

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Sukij Piyasirisilp, MD, Siriraj Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Anticipated): May 1, 2012
• Study Completion (Anticipated): August 1, 2012

Study Registration Dates

• First Submitted: July 20, 2009
• First Submitted That Met QC Criteria: February 15, 2011
• First Posted (Estimate): February 17, 2011

Study Record Updates

• Last Update Posted (Estimate): January 2, 2012
• Last Update Submitted That Met QC Criteria: December 29, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Antitubercular Agents; Antibiotics, Antitubercular; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Rifampin; Colistin
• Other Study ID Numbers: SirirajCEU51-001