Observational study on treatment effectiveness for Mycobacterium Avium Complex Pulmonary Disease

A Prospective, Multicenter, Single-arm MAC-PD Cohort: a NTM-NET and ESGMYC Collaborative Study

This study is trying to see how well a three-drug treatment works for people newly diagnosed with Mycobacterium avium complex pulmonary disease and how well they stick to the treatment plan.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Radboud University Medical Center (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 11 sites (Portland, Oregon and 10 other locations)
• Trial ID: NCT05906316 on ClinicalTrials.gov

What this trial studies

This study aims to gather prospective data on the effectiveness, adherence, and necessary adjustments to guideline-based three-drug antimycobacterial therapy in patients newly diagnosed with Mycobacterium avium complex pulmonary disease (MAC-PD). By collaborating with multiple medical centers, the study will systematically collect data over the first six months of treatment to address the challenges of low treatment success rates and high drug toxicity. The goal is to improve understanding of treatment outcomes and adherence in this patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals who have been newly diagnosed with MAC-PD and require three-drug antimycobacterial treatment.

Not a fit: Patients with poor general health, active malignancies, or those with certain co-morbid conditions such as HIV or cystic fibrosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies and outcomes for patients with Mycobacterium avium complex pulmonary disease.

How similar studies have performed: While there is limited data on similar prospective studies, the need for improved treatment outcomes in MAC-PD suggests that this approach could provide valuable insights.

Eligibility criteria

Inclusion Criteria:

* Newly diagnosed MAC-PD (primary or recurrent) as per the international NTM guideline that requires three-drug antimycobacterial treatment
* Signed and dated informed consent

Exclusion Criteria:

* The participant is in poor general condition where participation in the study cannot be accepted per discretion of the Investigator
* The participant has a known or suspected, current drug or alcohol abuse, that is, in the opinion of the Investigator, sufficient to compromise the safety or cooperation of the patient
* HIV-infection;
* Cystic fibrosis;
* \>1 month antibiotic treatment for current MAC infection;
* \< 6 months between previous antimycobacterial NTM-PD treatment and antimycobacterial treatment for current MAC-PD
* Disseminated MAC infection;
* Active pulmonary tuberculosis, fungal or nocardial disease requiring treatment;
* Active pulmonary malignancy (primary or metastatic) or any other malignancy requiring chemotherapy or radiotherapy within 6 months before screening or anticipated during the study period;

Where this trial is running

Portland, Oregon and 10 other locations

• Oregon Science and Health University — Portland, Oregon, United States (Recruiting)
• UZ Leuven — Leuven, Belgium (Recruiting)
• University of Calgary — Calgary, Alberta, Canada (Recruiting)
• University Hospital Center Zagreb — Zagreb, Croatia (Recruiting)
• Aarhus University Hospital — Aarhus, Denmark (Recruiting)
• Rasmus Rude Laub — Hellerup, Denmark (Recruiting)
• University Hospital Frankfurt — Frankfurt, Germany (Recruiting)
• Fukujuji Hospital — Tokyo, Japan (Recruiting)
• Radboud University Medical Center — Nijmegen, Netherlands (Recruiting)
• Seoul National University Hospital — Seoul, South Korea (Recruiting)
• Hospital Clínic de Barcelona — Barcelona, Spain (Recruiting)

Study contacts

• Principal investigator: Jakko van Ingen, MSc, PhD — Radboud University Medical Center
• Study coordinator: Arthur Lemson, MSc

Conditions Mycobacterium Avium Complex Pulmonary Disease