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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-03-31

Study Completion Date

2004-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Diseases

Keywords

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pulmonary disease Treatment of Opportunist Mycobacteria Clarithromycin Ciprofloxacin M.vaccae Pulmonary diseases caused by Opportunist Mycobacteria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Addition of clarithromycin to rifampicin and ethambutol

Intervention Type DRUG

Addition of Ciprofloxacin to rifampicin and ethambutol

Intervention Type DRUG

Vaccination with M.vaccae

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Ian Campbell, BSc MD FRCP

Role: PRINCIPAL_INVESTIGATOR

British Thoracic Society, Research Committee

Locations

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Llandough Hospital

Penarth, Vale of Glamorgan, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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BTS Opportunist Mycobacteria

Identifier Type: -

Identifier Source: org_study_id