Clarithromycin v Ciprofloxacin Added to Rifampicin + Ethambutol, for Opportunist Mycobacterial Pulmonary Disease
Phase 4
Completed
- Conditions
- Pulmonary Diseases
- Registration Number
- NCT00367913
- Lead Sponsor
- British Thoracic Society
- Brief Summary
To date key drugs in the treatment of MAIS, M.malmoense and M.xenopi (Opportunist Mycobacteria have been rifampicin and ethambutol. Clarithromycin and Ciprofloxacin are active in vitro against these species of mycobacteria. The primary aim of this study was to compare these to agents as supplements to rifampicin and ethambutol. A secondary aim was to assess the vale of immunotherapy with M.vaccae.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
- Patients with pulmonary disease due to M.avium intracellulare, M.malmoense or M.xenopi. Aged 16 or over. With clinical and/or radiological evidence of active infection and producing sputum positive on culture on at least 2 occasions.
Exclusion Criteria
- Pregnant women and women of childbearing age not taking adequate contraceptive precautions.
Patients who have sputum currently positive on culture for M.tuberculosis or M.bovis.
Patients who have AIDS or who are known to be HIV positive
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Death rates Cure rates Relapse rates Unwanted effects of therapy
- Secondary Outcome Measures
Name Time Method Benefit or not of immunotherapy with M.vaccae
Trial Locations
- Locations (1)
Llandough Hospital
🇬🇧Penarth, Vale of Glamorgan, United Kingdom