Non-tuberculous Mycobacterial Lung Infection with Mycobacterium avium Complex (MAC)
This study is evaluating the effectiveness and safety profile of a study medication on people who have been newly diagnosed with Nontuberculous Mycobacterial (NTM) lung infection caused by Mycobacterium avium complex (MAC) ("NTM lung disease caused by MAC")
You may be eligible if you:
- Have a current diagnosis of MAC lung infection
- Have not received treatment with antibiotics for current infection
- Have not previously had more than 3 MAC lung infections
- Have not tested positive for HIV
By participating in this study, you contribute to the understanding and treatment of NTM lung disease caused by MAC. The information gathered during and after the study could help other people living with this disease.
No, you will not have to pay for the study medication, study visits or any tests that are part of the study.
In addition, you will be reimbursed for any necessary expenses you may incur as a result of taking part in this study. For example: transportation expenses to and from the study site.
Certain restrictions may apply. Please let the study staff know if you have any questions about expenses.
The study is made up of 3 phases
1. SCREENING PHASE
You may be required to visit the study site several times during this phase to provide your medical history and have tests performed to make sure you are eligible to participate.
2. STUDY TREATMENT PHASE
If you are eligible to participate, you will be randomly assigned to one of 2 study groups. 1 group will receive standard of care plus the investigational drug and 1 group will receive standard of care plus placebo (sugar pill). Over the course of the Study Treatment Phase, you can expect to:
• Meet with your study doctor and team. Some of these visits will be done over the phone
• Be closely monitored by your study doctor for any changes in your condition, your medication or your overall health and quality of life
3. OFF-STUDY TREATMENT PHASE
Once you have completed study treatment, there will be an off-study treatment phase. During this time you will have 1-2 on-site follow-up visits with your study team. At your final on-site visit your study doctor will do another physical exam and perform any other tests needed to complete the study.
View study on ClinicalTrials.gov