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

Last updated: November 14, 2024
Sponsor: Radboud University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mac Infection (Mycobacterium Avium Complex)

Treatment

N/A

Clinical Study ID

NCT05906316
2022-13742
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Newly diagnosed MAC-PD (primary or recurrent) as per the international NTM guidelinethat requires three-drug antimycobacterial treatment

  • Signed and dated informed consent

Exclusion

Exclusion Criteria:

  • The participant is in poor general condition where participation in the study cannotbe accepted per discretion of the Investigator

  • The participant has a known or suspected, current drug or alcohol abuse, that is, inthe opinion of the Investigator, sufficient to compromise the safety or cooperationof the patient

  • HIV-infection;

  • Cystic fibrosis;

  • >1 month antibiotic treatment for current MAC infection;

  • < 6 months between previous antimycobacterial NTM-PD treatment and antimycobacterialtreatment 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 malignancyrequiring chemotherapy or radiotherapy within 6 months before screening oranticipated during the study period;

Study Design

Total Participants: 100
Study Start date:
July 01, 2023
Estimated Completion Date:
July 01, 2026

Study 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.

Connect with a study center

  • UZ Leuven

    Leuven,
    Belgium

    Active - Recruiting

  • University of Calgary

    Calgary, Alberta
    Canada

    Active - Recruiting

  • University Hospital Center Zagreb

    Zagreb,
    Croatia

    Active - Recruiting

  • Aarhus University Hospital

    Arhus,
    Denmark

    Active - Recruiting

  • Rasmus Rude Laub

    Hellerup,
    Denmark

    Active - Recruiting

  • Fukujuji Hospital

    Tokyo,
    Japan

    Active - Recruiting

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Radboud University Medical Center

    Nijmegen, 6511LK
    Netherlands

    Active - Recruiting

  • Hospital Clínic de Barcelona

    Barcelona,
    Spain

    Active - Recruiting

  • Oregon Science and Health University

    Portland, Oregon 97239
    United States

    Active - Recruiting

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