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

Sponsor

British Thoracic Society (Other)

Overall Status

Completed

CT.gov ID

NCT00367913

Collaborator

(none)

400

Enrollment

Location

114.1

Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Diseases	Drug: Addition of clarithromycin to rifampicin and ethambutol Drug: Addition of Ciprofloxacin to rifampicin and ethambutol Biological: Vaccination with M.vaccae	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Mar 1, 1995

Study Completion Date :

Sep 1, 2004

Outcome Measures

Primary Outcome Measures

Death rates []
Cure rates []
Relapse rates []
Unwanted effects of therapy []

Secondary Outcome Measures

Benefit or not of immunotherapy with M.vaccae []

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts 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.