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

British Thoracic Society400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Pulmonary Diseases

Interventions

Addition of clarithromycin to rifampicin and ethambutolDRUG

Addition of Ciprofloxacin to rifampicin and ethambutolDRUG

Vaccination with M.vaccaeBIOLOGICAL

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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 (1)

Llandough Hospital

Penarth, Vale of Glamorgan, United Kingdom

Outcomes

Primary Outcomes

Death rates

Cure rates

Relapse rates

Unwanted effects of therapy

Secondary Outcomes

Benefit or not of immunotherapy with M.vaccae

Data from ClinicalTrials.gov

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