Use of Clarithromycin and Rifabutin for the Treatment of M. Avium Complex (MAC) Lung Disease

This study is ongoing, but not recruiting participants.

First Received: January 11, 2008 No Changes Posted

Sponsor:	The University of Texas Health Science Center at Tyler
Collaborators:	Abbott Pfizer
Information provided by:	The University of Texas Health Science Center at Tyler
ClinicalTrials.gov Identifier:	NCT00598897

Purpose

To determine the safety and tolerance of clarithromycin given three times per week in combination with multiple drugs including rifabutin three times per week

Condition	Intervention	Phase
Mycobacterium Avium Complex Lung Disease	Drug: clarithromycin, rifabutin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Open, Noncomparative Trial of Multidrug Regimens Containing Clarithromycin and Rifabutin Administered Three Times Per Week for the Treatment of M. Avium Complex (MAC) Lung Disease

Resource links provided by NLM:

MedlinePlus related topics: Mycobacterial Infections

Drug Information available for: Rifabutin Clarithromycin

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center at Tyler:

Primary Outcome Measures:

Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures [ Time Frame: Monthly while on treatment, then followup after therapy discontinuation at one month, then at three months, then at 6 months, then annually, and prn for life ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine if treatment given three times weekly is as effective in producing sputum culture conversion as treatment given daily [ Time Frame: Monthly while on treatment, then followup after therapy discontinuation at one month, then at three months, then at 6 months, then annually, and prn for life ] [ Designated as safety issue: Yes ]

Enrollment:	89
Study Start Date:	August 1995
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Drug: clarithromycin, rifabutin Clarithromycin three times per week (variable dosage) in combination with multiple drugs including rifabutin three times per week (variable dosage). Dosage dependent on age, weight and other patient-specific health factors.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meet American Thoracic Society criteria for nontuberculous mycobacterial lung disease: two or more AFB smear positive, culture positive sputums or bronchoscopic samples and/or two or more AFB smear negative respiratory samples with moderate to heavy growth (2+-4+); abnormal CXR consistent with M. avium lung disease; absence of other potential mycobacterial or fungal lung pathogens (except for the coexistence of M. abscessus).
Adults age 18 and older
Pretreatment isolate of M. avium complex available for MIC determination

Exclusion Criteria:

History of allergy to study drugs
If a mensruating female, not pregnant and on adequate birth control.
Children less than 18 years of age
HIV + or at high risk for HIV infection.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598897

Locations

United States, Texas
The University of Texas Health Science Center at Tyler
Tyler, Texas, United States, 75708

Sponsors and Collaborators

The University of Texas Health Science Center at Tyler

Abbott

Pfizer

Investigators

Principal Investigator:

Richard J Wallace Jr., M.D.

The University of Texas Health Science Center at Tyler

More Information

No publications provided

Responsible Party:	The University of Texas Health Science Center at Tyler ( Richard J. Wallace Jr., M.D. )
Study ID Numbers:	447
Study First Received:	January 11, 2008
Last Updated:	January 11, 2008
ClinicalTrials.gov Identifier:	NCT00598897 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center at Tyler:

MAC

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Rifabutin
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions
Actinomycetales Infections
Mycobacterium Infections, Atypical
Antibiotics, Antitubercular
Mycobacterium avium-intracellulare Infection

Anti-Bacterial Agents
Clarithromycin
Protein Synthesis Inhibitors
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Therapeutic Uses
Lung Diseases
Mycobacterium Infections
Antitubercular Agents

ClinicalTrials.gov processed this record on February 08, 2010