Back to resultsAzithromycin in the Treatment of M. Avium Complex Lung Disease
Primary Purpose
Mycobacterium Avium Complex Lung Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Azithromycin
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 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; abnormal CXR consistent with M. avium lung disease; absence of other lung pathogens (except for the coexistence of M. abscessus).
- Age 18 and older
- Pretreatment isolate of M. avium complex available for MIC determination
Exclusion Criteria:
- History of macrolide allergy
- Received macrolide therapy in last two months
- 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
Experimental
Arm Label
Azithromycin
Arm Description
Azithromycin combined with 2 other drugs given 3 times weekly for MAc lung disease
Outcomes
Primary Outcome Measures
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures
neg cultures X3( sputum conversion)
Secondary Outcome Measures
Microbiological cultures
culture neg 1 yr on treatment
Full Information
NCT ID
NCT00599079
First Posted
January 11, 2008
Last Updated
May 19, 2017
Sponsor
The University of Texas Health Science Center at Tyler
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00599079
Brief Title
Azithromycin in the Treatment of M. Avium Complex Lung Disease
Official Title
Open, Noncomparative Trial of Azithromycin in 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
February 1993 (Actual)
Primary Completion Date
May 2008 (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
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the safety and efficacy of azithromycin in the treatment of lung infection with M.avium complex and M. abscessus lung disease.
Detailed Description
To study the safety and efficacy of azithromycin in combination treatment for M. abscessus and MAC lung disease
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
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Azithromycin
Arm Type
Experimental
Arm Description
Azithromycin combined with 2 other drugs given 3 times weekly for MAc lung disease
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Other Intervention Name(s)
Zithromax
Intervention Description
Azithromycin Daily Dosage dependent on clinical factos such as age, weight and patient specific health descriptors
Primary Outcome Measure Information:
Title
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures
Description
neg cultures X3( sputum conversion)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Microbiological cultures
Description
culture neg 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; abnormal CXR consistent with M. avium lung disease; absence of other lung pathogens (except for the coexistence of M. abscessus).
Age 18 and older
Pretreatment isolate of M. avium complex available for MIC determination
Exclusion Criteria:
History of macrolide allergy
Received macrolide therapy in last two months
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 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
Learn more about this trial
Azithromycin in the Treatment of M. Avium Complex Lung Disease
We'll reach out to this number within 24 hrs