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Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)

Sponsor
The University of Texas Health Science Center at Tyler (Other)
Overall Status
Completed
CT.gov ID
NCT00600769
Collaborator
Abbott (Industry)
210
Enrollment
1
Location
1
Arm
316.5
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Use of oral clarithromycin for treatment of chronic lung disease due to Mycobacterium avium-intracellulare and other non-tuberculous Mycobacteria

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Oral clarithromycin for treatment of MAC and other nontuberculous mycobacteria in adults with clinical history

Study Design

Study Type:
Interventional
Actual Enrollment :
210 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open Study of Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)
Actual Study Start Date :
Jan 1, 1991
Actual Primary Completion Date :
Nov 1, 2006
Actual Study Completion Date :
May 18, 2017

Arms and Interventions

Arm Intervention/Treatment
Other: treatment of MAC and other NTM

Clarithromycin drug given twice daily.

Drug: Clarithromycin
Dosage dependent on clinical factors such as age, weight and patient-specific health status
Other Names:
  • Biaxin

    		•

    Outcome Measures

    Primary Outcome Measures

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

      neg culture x3( sputum conversion)

    Secondary Outcome Measures

    1. Microbiological cultures [1yr]

      neg culture for 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; absence of other potential lung pathogens (except for the coexistence of M. abscessus)

    • Age 18 years and older

    Exclusion Criteria:

    • History of macrolide allergy

    • Must not receive the antihistamines terfenadine (Seldane) or astemizole (Hismanal) while on clarithromycin

    • 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
    • Abbott

    Investigators

    • Principal Investigator: Richard J Wallace, MD, UTHSCT

    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:
    NCT00600769
    Other Study ID Numbers:
    • 263
    First Posted:
    Jan 25, 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
    NTM
    Additional relevant MeSH terms:
    Mycobacterium Infections
    Mycobacterium avium-intracellulare Infection
    Clarithromycin

    Study Results

    No Results Posted as of May 23, 2017