Clarithromycin v Ciprofloxacin Added to Rifampicin + Ethambutol, for Opportunist Mycobacterial Pulmonary Disease

British Thoracic Society

Status and phase: Completed; Phase 4

Conditions: Pulmonary Diseases

Treatments: Biological: Vaccination with M.vaccae; Drug: Addition of Ciprofloxacin to rifampicin and ethambutol; Drug: Addition of clarithromycin to rifampicin and ethambutol

Study type: Interventional

Funder types: Other

Identifiers

NCT00367913

BTS Opportunist Mycobacteria

Details and patient eligibility

About

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.

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)