- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00600769
Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)
May 19, 2017 updated by: Richard J. Wallace, Jr., M.D., The University of Texas Health Science Center at Tyler
Open Study of Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)
Use of oral clarithromycin for treatment of chronic lung disease due to Mycobacterium avium-intracellulare and other non-tuberculous Mycobacteria
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Oral clarithromycin for treatment of MAC and other nontuberculous mycobacteria in adults with clinical history
Study Type
Interventional
Enrollment (Actual)
210
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Tyler, Texas, United States, 75708
- The University of Texas Health Science Center at Tyler
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: treatment of MAC and other NTM
Clarithromycin drug given twice daily.
|
Dosage dependent on clinical factors such as age, weight and patient-specific health status
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical and microbiological outcomes, such as clinical symptoms and laboratory cultures
Time Frame: 6 months
|
neg culture x3( sputum conversion)
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbiological cultures
Time Frame: 1yr
|
neg culture for 1 yr on treatment
|
1yr
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Richard J Wallace, MD, UTHSCT
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 1991
Primary Completion (Actual)
November 1, 2006
Study Completion (Actual)
May 18, 2017
Study Registration Dates
First Submitted
January 14, 2008
First Submitted That Met QC Criteria
January 14, 2008
First Posted (Estimate)
January 25, 2008
Study Record Updates
Last Update Posted (Actual)
May 23, 2017
Last Update Submitted That Met QC Criteria
May 19, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Mycobacterium Infections, Nontuberculous
- Mycobacterium Infections
- Mycobacterium avium-intracellulare Infection
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Protein Synthesis Inhibitors
- Clarithromycin
Other Study ID Numbers
- 263
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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