Back to resultsClarithromycin v Ciprofloxacin Added to Rifampicin + Ethambutol, for Opportunist Mycobacterial Pulmonary Disease
Primary Purpose
Pulmonary Diseases
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Addition of clarithromycin to rifampicin and ethambutol
Addition of Ciprofloxacin to rifampicin and ethambutol
Vaccination with M.vaccae
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Diseases focused on measuring pulmonary disease, Treatment of Opportunist Mycobacteria, Clarithromycin, Ciprofloxacin, M.vaccae, Pulmonary diseases caused by Opportunist Mycobacteria
Eligibility Criteria
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
Sites / Locations
- Llandough Hospital
Outcomes
Primary Outcome Measures
Death rates
Cure rates
Relapse rates
Unwanted effects of therapy
Secondary Outcome Measures
Benefit or not of immunotherapy with M.vaccae
Full Information
NCT ID
NCT00367913
First Posted
August 21, 2006
Last Updated
August 21, 2006
Sponsor
British Thoracic Society
1. Study Identification
Unique Protocol Identification Number
NCT00367913
Brief Title
Clarithromycin v Ciprofloxacin Added to Rifampicin + Ethambutol, for Opportunist Mycobacterial Pulmonary Disease
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 Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
March 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
British Thoracic Society
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Diseases
Keywords
pulmonary disease, Treatment of Opportunist Mycobacteria, Clarithromycin, Ciprofloxacin, M.vaccae, Pulmonary diseases caused by Opportunist Mycobacteria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Addition of clarithromycin to rifampicin and ethambutol
Intervention Type
Drug
Intervention Name(s)
Addition of Ciprofloxacin to rifampicin and ethambutol
Intervention Type
Biological
Intervention Name(s)
Vaccination with M.vaccae
Primary Outcome Measure Information:
Title
Death rates
Title
Cure rates
Title
Relapse rates
Title
Unwanted effects of therapy
Secondary Outcome Measure Information:
Title
Benefit or not of immunotherapy with M.vaccae
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Campbell, BSc MD FRCP
Organizational Affiliation
British Thoracic Society, Research Committee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Llandough Hospital
City
Penarth
State/Province
Vale of Glamorgan
ZIP/Postal Code
CF64 2XX
Country
United Kingdom
12. IPD Sharing Statement
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Clarithromycin v Ciprofloxacin Added to Rifampicin + Ethambutol, for Opportunist Mycobacterial Pulmonary Disease
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