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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00367913
Recruitment Status : Completed
First Posted : August 23, 2006
Last Update Posted : August 23, 2006
Information provided by:
British Thoracic Society

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 Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
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 : March 1995
Study Completion Date : September 2004

Primary Outcome Measures :
  1. Death rates
  2. Cure rates
  3. Relapse rates
  4. Unwanted effects of therapy

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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Identifier: NCT00367913     History of Changes
Other Study ID Numbers: BTS Opportunist Mycobacteria
First Posted: August 23, 2006    Key Record Dates
Last Update Posted: August 23, 2006
Last Verified: July 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