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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Richard J. Wallace, Jr., M.D., The University of Texas Health Science Center at Tyler
ClinicalTrials.gov Identifier:
NCT00600769
First received: January 14, 2008
Last updated: May 18, 2017
Last verified: May 2017
  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: No masking
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 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: Monthly while on treatment, then followup after therapy discontinuation will be at one month, then at 3 months, then at 6 months, then annually, and prn for life ]
    neg culture for 1 yr on treatment


Secondary Outcome Measures:
  • Microbiological cultures [ Time Frame: Monthly while on treatment, then followup after therapy discontinuation will be at one month, then at 3 months, then at 6 months, then annually, and prn for life ]
    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

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
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: 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
Study First Received: January 14, 2008
Last Updated: May 18, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by 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

ClinicalTrials.gov processed this record on May 22, 2017