Clarithromycin v Ciprofloxacin Added to Rifampicin + Ethambutol, for Opportunist Mycobacterial Pulmonary Disease
Information source: British Thoracic Society
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Diseases
Intervention: Addition of clarithromycin to rifampicin and ethambutol (Drug); Addition of Ciprofloxacin to rifampicin and ethambutol (Drug); Vaccination with M.vaccae (Biological)
Phase: Phase 4
Status: Completed
Sponsored by: British Thoracic Society Official(s) and/or principal investigator(s): Ian Campbell, BSc MD FRCP, Principal Investigator, Affiliation: British Thoracic Society, Research Committee
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.
Clinical Details
Official title: Treatment of Pulmonary Disease Caused by MAIS, M.Xenopi or M.Malmoense: A Comparison of Two Triple Drug Regimens and an Assessment of the Value of Immunotherapy With M.Vaccae
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Death ratesCure rates Relapse rates Unwanted effects of therapy
Secondary outcome: Benefit or not of immunotherapy with M.vaccae
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Llandough Hospital, Penarth, Vale of Glamorgan CF64 2XX, United Kingdom
Additional Information
Starting date: March 1995
Last updated: August 21, 2006
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