Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)
Primary Purpose
Nontuberculous Mycobacteria, Mycobacterium Avium Complex
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Clarithromycin
Sponsored by
About this trial
This is an interventional treatment trial for Nontuberculous Mycobacteria focused on measuring MAC, NTM
Eligibility 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
Sites / Locations
- The University of Texas Health Science Center at Tyler
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
treatment of MAC and other NTM
Arm Description
Clarithromycin drug given twice daily.
Outcomes
Primary Outcome Measures
Clinical and microbiological outcomes, such as clinical symptoms and laboratory cultures
neg culture x3( sputum conversion)
Secondary Outcome Measures
Microbiological cultures
neg culture for 1 yr on treatment
Full Information
NCT ID
NCT00600769
First Posted
January 14, 2008
Last Updated
May 19, 2017
Sponsor
The University of Texas Health Science Center at Tyler
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT00600769
Brief Title
Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)
Official Title
Open Study of Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 1991 (Actual)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
May 18, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at Tyler
Collaborators
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Use of oral clarithromycin for treatment of chronic lung disease due to Mycobacterium avium-intracellulare and other non-tuberculous Mycobacteria
Detailed Description
Oral clarithromycin for treatment of MAC and other nontuberculous mycobacteria in adults with clinical history
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nontuberculous Mycobacteria, Mycobacterium Avium Complex
Keywords
MAC, NTM
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment of MAC and other NTM
Arm Type
Other
Arm Description
Clarithromycin drug given twice daily.
Intervention Type
Drug
Intervention Name(s)
Clarithromycin
Other Intervention Name(s)
Biaxin
Intervention Description
Dosage dependent on clinical factors such as age, weight and patient-specific health status
Primary Outcome Measure Information:
Title
Clinical and microbiological outcomes, such as clinical symptoms and laboratory cultures
Description
neg culture x3( sputum conversion)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Microbiological cultures
Description
neg culture for 1 yr on treatment
Time Frame
1yr
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard J Wallace, MD
Organizational Affiliation
UTHSCT
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)
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