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Trial record 1 of 1 for:    "Mycobacterium Malmoense"
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Clarithromycin v Ciprofloxacin Added to Rifampicin + Ethambutol, for Opportunist Mycobacterial Pulmonary Disease

This study has been completed.
Information provided by:
British Thoracic Society Identifier:
First received: August 21, 2006
Last updated: NA
Last verified: July 2006
History: No changes posted
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 Intervention 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 Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by British Thoracic Society:

Primary Outcome Measures:
  • Death rates
  • Cure rates
  • Relapse rates
  • Unwanted effects of therapy

Secondary Outcome Measures:
  • Benefit or not of immunotherapy with M.vaccae

Estimated Enrollment: 400
Study Start Date: March 1995
Estimated Study Completion Date: September 2004

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00367913

United Kingdom
Llandough Hospital
Penarth, Vale of Glamorgan, United Kingdom, CF64 2XX
Sponsors and Collaborators
British Thoracic Society
Principal Investigator: Ian Campbell, BSc MD FRCP British Thoracic Society, Research Committee
  More Information Identifier: NCT00367913     History of Changes
Other Study ID Numbers: BTS Opportunist Mycobacteria
Study First Received: August 21, 2006
Last Updated: August 21, 2006

Keywords provided by British Thoracic Society:
pulmonary disease
Treatment of Opportunist Mycobacteria
Pulmonary diseases caused by Opportunist Mycobacteria

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers processed this record on September 21, 2017