Observational study on treatment effectiveness for Mycobacterium Avium Complex Pulmonary Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Jakko van Ingen, MSc, PhD — Radboud University Medical Center
• Study coordinator: Arthur Lemson, MSc
• Email: arthur.lemson@radboudumc.nl
• Phone: +31634265743

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Shortened contezolid-enhanced treatment for Mycobacterium avium complex lung disease

  This study will try adding contezolid to standard antibiotics to see if adults with Mycobacterium avium complex lung disease can have lower bacterial counts, less lung damage, and better quality of life with a 6-month treatment.

  Recruiting at 4 sites Phase 4 Capital Medical University · Hefei, Anhui and 5 other locations · NCT07213765

• Preventing MAC lung disease from coming back with Cordyceps sinensis capsules

  This trial will test whether taking a daily Cordyceps sinensis (Bailiing) capsule for 12 months can prevent recurrence of Mycobacterium avium complex (MAC) lung disease in adults who have been microbiologically cured.

  Recruiting at 3 sites Phase 4 Capital Medical University · Hefei, Anhui and 5 other locations · NCT07174076

• Short-term bactericidal effect of contezolid for Mycobacterium avium complex lung disease

  This trial tests whether giving adults with MAC pulmonary disease contezolid in addition to the usual antibiotics helps reduce bacteria in sputum and checks for safety.

  Recruiting at 2 sites Phase 4 Capital Medical University · Beijing, Beijing Municipality and 2 other locations · NCT07084402

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.