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Use of Azithromycin and Rifabutin Administered 3 Times Weekly for the Treatment of M. Avium Complex (MAC) Lung Disease

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Richard J. Wallace, Jr., M.D., The University of Texas Health Science Center at Tyler
ClinicalTrials.gov Identifier:
NCT00598962
First received: January 11, 2008
Last updated: May 19, 2017
Last verified: May 2017
  Purpose
To determine the safety and efficacy of azithromycin, rifabutin and ethambutol given three times weekly in the treatment of lung infection with M. avium complex(MAC)

Condition Intervention Phase
Mycobacterium Avium Complex
Drug: Azithromycin
Drug: Rifabutin/rifampin
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 Azithromycin 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 Richard J. Wallace, Jr., M.D., 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 ]
    neg cultures X3 ( sputum conversion)


Secondary Outcome Measures:
  • Microbiological cultures [ Time Frame: 1yr ]
    neg culture 1 yr on treatment


Enrollment: 58
Actual Study Start Date: December 1994
Study Completion Date: May 18, 2017
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: azithromycin and rifabutin/rifampin
Azithromycin and rifabutin/rifampin administered three times weekly.
Drug: Azithromycin
Dosage dependent on clinical factors such as age, weight and patient-specific health status
Other Name: Zithromax
Drug: Rifabutin/rifampin
Other Name: mycobutin/

Detailed Description:
Azithromycin given 3 times weekly along with rifampin/rifabutin and ethambutol for treatment of MAC
  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 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; abnormal CXR consistent with M. avium lung disease; absence of other lung pathogens (except for the coexistence of M. abscessus).
  • Age 18 and older
  • Pretreatment isolate of M. avium complex available for MIC determination
  • Baseline laboratory and clinical testing for baseline CBC, Chemistry (including liver enzymes), hearing test, visual acuity and color discrimination
  • Available for long term followup

Exclusion Criteria:

  • History of macrolide or rifamycins allergy
  • Laboratory evidence of mycobacterial resistance to azithromycin
  • Children less than 18 years of age
  • If a menstruating female, not pregnant and on adequate birth control
  • HIV+ or at risk
  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: NCT00598962

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
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: NCT00598962     History of Changes
Other Study ID Numbers: 426
Study First Received: January 11, 2008
Last Updated: May 19, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Richard J. Wallace, Jr., M.D., 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
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

ClinicalTrials.gov processed this record on May 25, 2017