Clarithromycin v Ciprofloxacin Added to Rifampicin + Ethambutol, for Opportunist Mycobacterial Pulmonary Disease - Full Text View

Sponsor:	British Thoracic Society
Information provided by:	British Thoracic Society
ClinicalTrials.gov Identifier:	NCT00367913

Purpose

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 IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: 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:

MedlinePlus related topics: Mycobacterial Infections

Drug Information available for: Rifampin Clarithromycin Ciprofloxacin Ciprofloxacin hydrochloride Ethambutol Ciprofloxacin lactate Ethambutol hydrochloride

U.S. FDA Resources

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

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367913

Locations

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

Sponsors and Collaborators

British Thoracic Society

Investigators

Principal Investigator:

Ian Campbell, BSc MD FRCP

British Thoracic Society, Research Committee

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00367913 History of Changes
Other Study ID Numbers:	BTS Opportunist Mycobacteria
Study First Received:	August 21, 2006
Last Updated:	August 21, 2006
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by British Thoracic Society:

pulmonary disease
Treatment of Opportunist Mycobacteria
Clarithromycin

Ciprofloxacin
M.vaccae
Pulmonary diseases caused by Opportunist Mycobacteria

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Respiratory Tract Diseases
Ciprofloxacin
Rifampin
Ethambutol
Clarithromycin
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Antitubercular Agents
Anti-Bacterial Agents
Antibiotics, Antitubercular
Leprostatic Agents
Protein Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012