A randomised, placebo controlled trial of rifampicin for the treatment of Staphylococcus aureus bacteraemia

Phase 1

• Conditions: S. aureus bacteraemia; MedDRA version: 14.1 Level: LLT Classification code 10058887 Term: Staphylococcus aureus bacteremia System Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1 Level: LLT Classification code 10054638 Term: Staphylococcus aureus septicemia System Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1 Level: LLT Classification code 10058863 Term: Staphylococcus aureus bacteraemia System Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1 Level: LLT Classification code 10041943 Term: Staphylococcus aureus septicaemia System Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1 Level: LLT Classification code 10058867 Term: Methicillin-resistant staphylococcal aureus sepsis System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-000344-10-GB
• Lead Sponsor: Medical Research Council

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-28
• Study Completion: 2017-01-18
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 758

Inclusion Criteria

1. Adults (18 years or older) 2. Staphylococcus aureus (meticillin-susceptible or resistant) grown from at least one blood culture 3. Less than 96 hours of active antibiotic therapy for the current infection 4. Patient or legal representative (LR) provides written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 640
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

1. Infection not caused by S. aureus alone in the opinion of the infection specialist (e.g. S. aureus is considered a blood culture contaminant, or polymicrobial culture with another organism likely to be contributing clinically to the current infection) 2. Sensitivity results already available and demonstrate rifampicin resistant S. aureus (defined by British Society for Antimicrobial Chemotherapy in vitro disc susceptibility testing) 3. Infection specialist considers rifampicin is contraindicated for any reason 4. Infection specialist considers rifampicin treatment is mandatory for any reason 5. Suspected active infection with Mycobacterium tuberculosis 6. Previously been randomised in ARREST for a prior episode of S. aureus bacteraemia

Study & Design

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