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ClinicalTrials.gov ID

NCT05906316

Lead Sponsor

Radboud University Medical CenterOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

100Estimated

Last Update Posted

Jun 26, 2025Actual

Start Date

Jul 1, 2023Actual

Primary Completion Date

Jan 1, 2026Estimated

Completion Date

Jul 1, 2026Estimated

Official Title

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

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.

Detailed Description

Mycobacterium avium complex (MAC) is the most frequent causative species that results in nontuberculous mycobacterial pulmonary disease (NTM-PD). Current treatment outcomes for MAC-PD are unsatisfactory with sputum culture conversion rates between 50-70%.The high prevalence of drug toxicity and low adherence to guideline-based treatment (GBT) are key reasons for the limited treatment success. Hence, there is an unmet need for prospective data on effectiveness of, adherence and adjustments to MAC-PD treatment regimens. By collaborating with NTM-NET and ESGMYC affiliated medical centers, we enable systematic, prospective data collection of an international MAC-PD cohort.

• Mycobacterium Avium Complex Pulmonary Disease

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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;

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Radboud University Medical CenterOTHER

natalie.lorent@uzleuven.be+32 16 33 22 11