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

Mahidol University

Status and phase: Unknown; Phase 3

Conditions: Drug Safety

Treatments: Drug: Colistin; Drug: Colistin plus Rifampicin

Study type: Interventional

Funder types: Other

Identifiers

NCT01297855

SirirajCEU51-001

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Colistin

Active Comparator group

Description:

Colistate

Treatment:

Drug: Colistin

Colistin plus Rifampicin

Experimental group

Description:

Colistate Rifampin

Treatment:

Drug: Colistin plus Rifampicin