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

NCT ID: NCT05906316

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2026-07-01

Brief Summary

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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

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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.

Conditions

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Mycobacterium Avium Complex Pulmonary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jakko van Ingen, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Oregon Science and Health University

Portland, Oregon, United States

Site Status RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

University of Calgary

Calgary, Alberta, Canada

Site Status RECRUITING

University Hospital Center Zagreb

Zagreb, , Croatia

Site Status RECRUITING

Aarhus University Hospital

Aarhus, , Denmark

Site Status RECRUITING

Rasmus Rude Laub

Hellerup, , Denmark

Site Status RECRUITING

University Hospital Frankfurt

Frankfurt, , Germany

Site Status RECRUITING

Fukujuji Hospital

Tokyo, , Japan

Site Status RECRUITING

Radboud University Medical Center

Nijmegen, , Netherlands

Site Status RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Hospital Clínic de Barcelona

Barcelona, , Spain

Site Status RECRUITING

Countries

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United States Belgium Canada Croatia Denmark Germany Japan Netherlands South Korea Spain

Central Contacts

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Arthur Lemson, MSc

Role: CONTACT

+31634265743

Wouter Hoefsloot, MSc, PhD

Role: CONTACT

+31611072569

Facility Contacts

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Kevin Winthrop, MD, MPH

Role: primary

Natalie Lorent, MD, PhD

Role: primary

+32 16 33 22 11

Christina Thornton, MD, PhD, FRCPC

Role: primary

+1 403-220-5110

Mateja Janković Makek, MD, PhD

Role: primary

Andreas Fløe Hvass, MD, PhD

Role: primary

+45 70 11 31 31

Role: primary

+45 38 67 38 67

Nils Wetzstein

Role: primary

Masashi Ito, MD, PhD

Role: primary

Arthur Lemson, MD

Role: primary

+31634265743

Wouter Hoefsloot, MD, PhD

Role: backup

+31611072569

Nakwon Kwak

Role: primary

Julian Gonzalez-Martin, MD, PhD

Role: primary

+34 932 27 54 00

Other Identifiers

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2022-13742

Identifier Type: -

Identifier Source: org_study_id

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