RANDOMISED, OPEN-LABEL CLINICAL TRIAL ON THE EFFICACY OF COLISTIN PLUS RIFAMPICIN TREATMENT VERSUS COLISTIN ALONE FOR SEVERE INFECTIONS BY MULTIDRUG-RESISTANT ACINETOBACTER BAUMANNII - COLISTIN AND RIFAMPICIN FOR MDR-ACINETOBACTER

• Conditions: Severe nosocomial infections due to multi-drug resistant Acinetobacter baumannii; MedDRA version: 9.1Level: SOCClassification code 10021881

• Registration Number: EUCTR2008-005078-10-IT
• Lead Sponsor: AZIENDA OSPEDALIERA VINCENZO MONALDI DI NAPOLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-11
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Microbiological evidence of severe infection due to multi-drug resistant A. baumannii during hospitalization, with susceptibility of the isolate to colistin (MIC 2 mg/l), irrespective of the susceptibility to rifampicin.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria will be as follows: age below 18 years; treatment with one of the study drugs prior to the diagnosis of A. baumannii infection; severe liver dysfunction; history of prior hypersensitivity to the study drugs.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified