Recruiting

MAC-PD

Sponsor:

Radboud University Medical Center

Code:

NCT05906316

Conditions

Mycobacterium Avium Complex Pulmonary Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

To gain insight in the effectiveness of, adherence and adjustments to guideline-based three-drug antimycobacterial therapy in patients with Mycobacterium avium complex pulmonary disease (MAC-PD) during the first 6 months of treatment.

Conditions

Mycobacterium Avium Complex Pulmonary Disease

Study ID

NCT05906316

Start date

Jul 1, 2023

Status verified date

Nov, 2024

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Jan 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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;

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Culture conversion rate [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Arthur Lemson, MSc

+31634265743arthur.lemson@radboudumc.nl

Wouter Hoefsloot, MSc, PhD

+31611072569wouter.hoefsloot@radboudumc.nl

Locations

Oregon Science and Health University

Recruiting

Portland, Oregon, United States, 97239

University of Calgary

Recruiting

Calgary, Alberta, Canada

Contacts

Christina Thornton, MD, PhD, FRCPC

+1 403-220-5110Christina.Thornton@albertahealthservices.ca

More Information

Sponsor

Radboud University Medical Center

Last update posted

Jun 26, 2025

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Radboud University Medical Center on 2025-06-26.