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

Sponsor
The University of Texas Health Science Center at Tyler (Other)
Overall Status
Completed
CT.gov ID
NCT00598962
Collaborator
Pfizer (Industry)
58
Enrollment
1
Location
1
Arm
269.5
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine the safety and efficacy of azithromycin, rifabutin and ethambutol given three times weekly in the treatment of lung infection with M. avium complex(MAC)

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Azithromycin given 3 times weekly along with rifampin/rifabutin and ethambutol for treatment of MAC

Study Design

Study Type:
Interventional
Actual Enrollment :
58 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
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
Actual Study Start Date :
Dec 1, 1994
Actual Primary Completion Date :
Nov 1, 2006
Actual Study Completion Date :
May 18, 2017

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Zithromax

    • Drug: Rifabutin/rifampin
    Other Names:
  • mycobutin/

    		•

    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]

      neg culture 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

    • 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

    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:
    NCT00598962
    Other Study ID Numbers:
    • 426
    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
    Rifampin
    Rifabutin

    Study Results

    No Results Posted as of May 23, 2017