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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00600769
First Posted: January 25, 2008
Last Update Posted: May 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Abbott
Information provided by (Responsible Party):
Richard J. Wallace, Jr., M.D., The University of Texas Health Science Center at Tyler
  Purpose
Use of oral clarithromycin for treatment of chronic lung disease due to Mycobacterium avium-intracellulare and other non-tuberculous Mycobacteria

Condition Intervention Phase
Nontuberculous Mycobacteria Mycobacterium Avium Complex Drug: Clarithromycin Phase 4

Study Type: Interventional
Study Design: 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)

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 culture x3( sputum conversion)


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


Enrollment: 210
Actual Study Start Date: January 1991
Study Completion Date: May 18, 2017
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Biaxin

Detailed Description:
Oral clarithromycin for treatment of MAC and other nontuberculous mycobacteria in adults with clinical history
  Eligibility

Information from the National Library of Medicine

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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; 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00600769


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
Abbott
Investigators
Principal Investigator: Richard J Wallace, MD UTHSCT
  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: NCT00600769     History of Changes
Other Study ID Numbers: 263
First Submitted: January 14, 2008
First Posted: January 25, 2008
Last Update Posted: May 23, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Richard J. Wallace, Jr., M.D., The University of Texas Health Science Center at Tyler:
MAC
NTM

Additional relevant MeSH terms:
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Mycobacterium Infections, Nontuberculous
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors