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

This study has been completed.
Sponsor:
Collaborators:
Abbott
Pfizer
Information provided by (Responsible Party):
Richard J. Wallace, Jr., M.D., The University of Texas Health Science Center at Tyler
ClinicalTrials.gov Identifier:
NCT00598897
First received: January 11, 2008
Last updated: May 19, 2017
Last verified: May 2017
  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 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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:


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: 6 months ]
    sputum conversion culture neg x3


Secondary Outcome Measures:
  • Clinical and microbiological outcomes [ Time Frame: 1 yr ]
    culture neg 1 yr on treatment


Enrollment: 89
Actual Study Start Date: August 1995
Study Completion Date: May 18, 2017
Primary Completion Date: August 7, 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: clarithromycin and rifabutin/rifampin
Clarithromycin and rifabutin/rifampin with ethambutol given three times weekly.
Drug: clarithromycin, rifabutin
Clarithromycin three times per week (variable dosage) in combination with multiple drugs including rifabutin or rifampin three times per week (variable dosage). Dosage dependent on age, weight and other patient-specific health factors.
Other Name: Biaxin, mycobutin

Detailed Description:
Safety and tolerance of clarithromycin given 3 times weekly with multiple drugs including ethambutol and rifampin/rifabutin
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Richard J. Wallace, Jr., M.D., Chairman Department of Microbiology, The University of Texas Health Science Center at Tyler
ClinicalTrials.gov Identifier: NCT00598897     History of Changes
Other Study ID Numbers: 447
Study First Received: January 11, 2008
Last Updated: May 19, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: No plan to share.

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

Additional relevant MeSH terms:
Lung Diseases
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Respiratory Tract Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Mycobacterium Infections, Nontuberculous
Rifabutin
Rifampin
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antitubercular
Antitubercular Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
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
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 23, 2017