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OpenTrials
Completed

NCT Number: NCT00367913

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

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.

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Key information

Conditions

Pulmonary Diseases Lung Diseases Respiratory Tract Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Llandough Hospital

Penarth, Vale of Glamorgan, CF64 2XX, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Addition of clarithromycin to rifampicin and ethambutol

Drug

Addition of Ciprofloxacin to rifampicin and ethambutol

Drug

Vaccination with M.vaccae

Biological

Primary outcomes

  1. Death rates

  2. Cure rates

  3. Relapse rates

  4. Unwanted effects of therapy

Secondary outcomes

  1. Benefit or not of immunotherapy with M.vaccae

Sponsors and collaborators

Lead sponsor

British Thoracic Society

Other

Registry information

Official study 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

Important dates

Study start
1995
Study completion
2004
First posted
Aug 23, 2006
Registry last updated
Aug 23, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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