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Azithromycin in the Treatment of M. Avium Complex 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:
NCT00599079
First received: January 11, 2008
Last updated: May 19, 2017
Last verified: May 2017
  Purpose
To determine the safety and efficacy of azithromycin in the treatment of lung infection with M.avium complex and M. abscessus lung disease.

Condition Intervention Phase
Mycobacterium Avium Complex Lung Disease
Drug: Azithromycin
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Open, Noncomparative Trial of Azithromycin in 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 ]
    culture neg 1 yr on treatment


Enrollment: 66
Actual Study Start Date: February 1993
Study Completion Date: May 18, 2017
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azithromycin
Azithromycin combined with 2 other drugs given 3 times weekly for MAc lung disease
Drug: Azithromycin
Azithromycin Daily Dosage dependent on clinical factos such as age, weight and patient specific health descriptors
Other Name: Zithromax

Detailed Description:
To study the safety and efficacy of azithromycin in combination treatment for M. abscessus and MAC lung disease
  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

Exclusion Criteria:

  • History of macrolide allergy
  • Received macrolide therapy in last two months
  • Children less than 18 years of age
  • If a menstruating female, not pregnant and on adequate birth control
  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: NCT00599079

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: NCT00599079     History of Changes
Other Study ID Numbers: 340
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

ClinicalTrials.gov processed this record on May 25, 2017