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

Pulmonary Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00367913
• Other study ID #: BTS Opportunist Mycobacteria
• Status: Completed
• Phase: Phase 4
• First received: August 21, 2006
• Last updated: August 21, 2006
• Start date: March 1995
• Est. completion date: September 2004

Study information

• Verified date: July 2006
• Source: British Thoracic Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Diseases

Intervention

Drug:
• Addition of clarithromycin to rifampicin and ethambutol

• Addition of Ciprofloxacin to rifampicin and ethambutol

Biological:
• Vaccination with M.vaccae

Locations

Country	Name	City	State
United Kingdom	Llandough Hospital	Penarth	Vale of Glamorgan

Sponsors (1)

Lead Sponsor	Collaborator
British Thoracic Society

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death rates
Primary	Cure rates
Primary	Relapse rates
Primary	Unwanted effects of therapy
Secondary	Benefit or not of immunotherapy with M.vaccae