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Drug Safety | Colistin Plus Rifampicin in MDR P. Aeruginosa and A. Baumanii

Drug Safety research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Drug Safety

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:ColistinColistimethate Sodium dose 2.5-5mg/kg/day

Drug:Colistin plus RifampicinColistin 2.5 to 5 mg/ Kg/ day Rifampin 10 mg/ Kg/ day

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

ColistinColistate

Colistin plus RifampicinColistate Rifampin

Study Status

Unknown status

Start Date: June 2010

Completed Date: August 2012

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: number of subjects with cure or improvement

Secondary Outcome: number of subjects with eradication of causative bacteria

Study sponsors, principal investigator, and references

Principal Investigator: Sukij Piyasirisilp, MD

Lead Sponsor: Mahidol University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01297855

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