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Azithromycin in the Treatment of M. Avium Complex Lung Disease

Sponsor
The University of Texas Health Science Center at Tyler (Other)
Overall Status
Completed
CT.gov ID
NCT00599079
Collaborator
Pfizer (Industry)
66
Enrollment
1
Location
1
Arm
291.5
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine the safety and efficacy of azithromycin in the treatment of lung infection with M.avium complex and M. abscessus lung disease.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open, Noncomparative Trial of Azithromycin in the Treatment of M.Avium Complex (MAC) Lung Disease
Actual Study Start Date :
Feb 1, 1993
Actual Primary Completion Date :
May 1, 2008
Actual Study Completion Date :
May 18, 2017

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Zithromax

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures [6 months]

      neg cultures X3( sputum conversion)

    Secondary Outcome Measures

    1. Microbiological cultures [1yr]

      culture neg 1 yr on treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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
    Other Study ID Numbers:
    • 340
    First Posted:
    Jan 23, 2008
    Last Update Posted:
    May 23, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Richard J. Wallace, Jr., M.D., Chairman Department of Microbiology, The University of Texas Health Science Center at Tyler
    MAC
    Additional relevant MeSH terms:
    Mycobacterium avium-intracellulare Infection
    Lung Diseases
    Azithromycin

    Study Results

    No Results Posted as of May 23, 2017