Clofazimine in the Treatment of Pulmonary Mycobacterium Avium Complex (MAC)
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ClinicalTrials.gov Identifier: NCT02968212 |
Recruitment Status :
Recruiting
First Posted : November 18, 2016
Last Update Posted : March 27, 2024
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Sponsor:
Oregon Health and Science University
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Jewish Health
The University of Texas Health Science Center at Tyler
National Institute of Allergy and Infectious Diseases (NIAID)
University of Chicago
Temple University
University of South Florida
Information provided by (Responsible Party):
Kevin Winthrop, Oregon Health and Science University
Tracking Information | |||||||||
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First Submitted Date ICMJE | November 10, 2016 | ||||||||
First Posted Date ICMJE | November 18, 2016 | ||||||||
Last Update Posted Date | March 27, 2024 | ||||||||
Actual Study Start Date ICMJE | April 11, 2017 | ||||||||
Estimated Primary Completion Date | December 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Change from Baseline sputum culture at 24 weeks [ Time Frame: Sputum examined for culture change from Baseline at 24 weeks ] sputum will be processed for acid fast bacilli stain/acid fast bacterial culture. A semi-quantitative assessment will be made by colony count for patients.
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Original Primary Outcome Measures ICMJE |
Change from Baseline sputum culture at 24 weeks [ Time Frame: Sputum examined for culture change from Baseline at 24 weeks ] | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Clofazimine in the Treatment of Pulmonary Mycobacterium Avium Complex (MAC) | ||||||||
Official Title ICMJE | Phase 2 Study of Clofazimine for the Treatment of Pulmonary Mycobacterium Avium Disease | ||||||||
Brief Summary | The purpose of this study is to evaluate the clinical effectiveness and safety of clofazimine when used to treat Mycobacteria avium complex (MAC) lung disease. Funding Source - FDA OOPD |
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Detailed Description | Clofazimine is an orphan antibiotic drug that is no longer available through pharmacies in the United States. It is approved for the treatment of Mycobacterium leprae (leprosy) infections. Clofazimine has been used for many years off-label against other Mycobacterium, including Mycobacteria avium complex (MAC) lung disease, an increasingly prevalent infection in older Americans. The U.S. Food and Drug Administration currently oversees clofazimine use to treat MAC lung disease through a special investigational drug access program. However, to date, there is little understanding of the benefits and risks of clofazimine when used to treat MAC lung disease. Accordingly, the investigators have developed a randomized, placebo-controlled clinical trial to assess the clinical efficacy and safety of clofazimine. To be eligible, participants must have MAC lung disease, positive sputum cultures for MAC, and not currently taking antibiotics for MAC. Eligible participants (102 total enrolled) will be randomly given either clofazimine or placebo for 6 months, and followed closely by their treating physician. The percentage of participants who become culture negative in each group will be compared, as it is suspected that participants treated with clofazimine will be more likely to become culture negative. The safety of clofazimine will be measured as well as other potential benefits of the therapy including changes in lung function and quality of life. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Mycobacterium Avium Complex | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
102 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | April 2025 | ||||||||
Estimated Primary Completion Date | December 2024 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT02968212 | ||||||||
Other Study ID Numbers ICMJE | FD-R-5401 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Kevin Winthrop, Oregon Health and Science University | ||||||||
Original Responsible Party | Kevin Winthrop, Oregon Health and Science University, Associate Professor | ||||||||
Current Study Sponsor ICMJE | Oregon Health and Science University | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Oregon Health and Science University | ||||||||
Verification Date | March 2024 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |