A Study of Clofazimine for Treating Patients with Drug Resistant Non-Tuberculous Mycobacterial Infections
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-006206
Sponsor Protocol Number: 16-006206
About this study
The purpose of this study is to determine if Clofazimine is effective in treating patients with drug resistant non-tuberculous mycobacterial infections.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- History of culture positive mycobacterial disease or refractory EP-NTM disease that has indicated resistance to first line agents and sensitivity to Clofazimine, or an additional drug needs to be added to the regimen because of inadequate response to existing therapy
- History of culture positive mycobacterial disease that is sensitive to Clofazimine, and has experienced an allergic or adverse reaction to other agents that prevent their use
- Clinical disease that has responded to treatment with antimycobacterial drugs but experienced allergic or adverse reactions to these agents that has prevented continued use or experienced a relapse in disease that necessitates the addition, or substitution, of second-line agents
- Has signed an informed consent
Exclusion Criteria
- Mycobacterial disease can be adequately treated by other available medications
- Allergy or a severe adverse reaction to Clofazimine in the past
- Is unable or unwilling to sign the informed consent
- Life expectancy of less than 6 months
- Unable to swallow capsules
- Has HIV infection
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Aaron Tande, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available