Use of Clarithromycin and Rifabutin for the Treatment of M. Avium Complex (MAC) Lung Disease
Primary Purpose
Mycobacterium Avium Complex Lung Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
clarithromycin, rifabutin
Sponsored by
About this trial
This is an interventional treatment trial for Mycobacterium Avium Complex Lung Disease focused on measuring MAC
Eligibility Criteria
Inclusion Criteria:
- Meet American Thoracic Society criteria for nontuberculous mycobacterial 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 mycobacterial or fungal lung pathogens (except for the coexistence of M. abscessus).
- Adults age 18 and older
- Pretreatment isolate of M. avium complex available for MIC determination
Exclusion Criteria:
- History of allergy to study drugs
- If a mensruating female, not pregnant and on adequate birth control.
- Children less than 18 years of age
- HIV + or at high risk for HIV infection.
Sites / Locations
- The University of Texas Health Science Center at Tyler
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
clarithromycin and rifabutin/rifampin
Arm Description
Clarithromycin and rifabutin/rifampin with ethambutol given three times weekly.
Outcomes
Primary Outcome Measures
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures
sputum conversion culture neg x3
Secondary Outcome Measures
Clinical and microbiological outcomes
culture neg 1 yr on treatment
Full Information
NCT ID
NCT00598897
First Posted
January 11, 2008
Last Updated
May 19, 2017
Sponsor
The University of Texas Health Science Center at Tyler
Collaborators
Abbott, Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00598897
Brief Title
Use of Clarithromycin and Rifabutin for the Treatment of M. Avium Complex (MAC) Lung Disease
Official Title
Open, Noncomparative Trial of Multidrug Regimens Containing Clarithromycin and Rifabutin Administered Three Times Per Week for the Treatment of M. Avium Complex (MAC) Lung Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 1995 (Actual)
Primary Completion Date
August 7, 2002 (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, Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the safety and tolerance of clarithromycin given three times per week in combination with multiple drugs including rifabutin three times per week
Detailed Description
Safety and tolerance of clarithromycin given 3 times weekly with multiple drugs including ethambutol and rifampin/rifabutin
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycobacterium Avium Complex Lung Disease
Keywords
MAC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
clarithromycin and rifabutin/rifampin
Arm Type
Experimental
Arm Description
Clarithromycin and rifabutin/rifampin with ethambutol given three times weekly.
Intervention Type
Drug
Intervention Name(s)
clarithromycin, rifabutin
Other Intervention Name(s)
Biaxin, mycobutin
Intervention Description
Clarithromycin three times per week (variable dosage) in combination with multiple drugs including rifabutin or rifampin three times per week (variable dosage). Dosage dependent on age, weight and other patient-specific health factors.
Primary Outcome Measure Information:
Title
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures
Description
sputum conversion culture neg x3
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Clinical and microbiological outcomes
Description
culture neg 1 yr on treatment
Time Frame
1 yr
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 mycobacterial 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 mycobacterial or fungal lung pathogens (except for the coexistence of M. abscessus).
Adults age 18 and older
Pretreatment isolate of M. avium complex available for MIC determination
Exclusion Criteria:
History of allergy to study drugs
If a mensruating female, not pregnant and on adequate birth control.
Children less than 18 years of age
HIV + or at high risk for HIV infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard J Wallace Jr., M.D.
Organizational Affiliation
The University of Texas Health Science Center at Tyler
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
IPD Sharing Plan Description
No plan to share.
Learn more about this trial
Use of Clarithromycin and Rifabutin for the Treatment of M. Avium Complex (MAC) Lung Disease
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