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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 rates

Cure 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

Page last updated: August 23, 2015

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