Pulmonary Diseases
Conditions
Keywords
pulmonary disease, Treatment of Opportunist Mycobacteria, Clarithromycin, Ciprofloxacin, M.vaccae, Pulmonary diseases caused by Opportunist Mycobacteria
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.
Interventions
DRUGAddition of clarithromycin to rifampicin and ethambutol
DRUGAddition of Ciprofloxacin to rifampicin and ethambutol
BIOLOGICALVaccination with M.vaccae
Sponsors
British Thoracic Society
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death rates | — |
| Cure rates | — |
| Relapse rates | — |
| Unwanted effects of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Benefit or not of immunotherapy with M.vaccae | — |
Countries
United Kingdom
Outcome results
None listed