RecruitingNCT05906316

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


Sponsor

Radboud University Medical Center

Enrollment

100 participants

Start Date

Jul 1, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria9

  • 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;

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Locations(11)

Oregon Science and Health University

Portland, Oregon, United States

UZ Leuven

Leuven, Belgium

University of Calgary

Calgary, Alberta, Canada

University Hospital Center Zagreb

Zagreb, Croatia

Aarhus University Hospital

Aarhus, Denmark

Rasmus Rude Laub

Hellerup, Denmark

University Hospital Frankfurt

Frankfurt, Germany

Fukujuji Hospital

Tokyo, Japan

Radboud University Medical Center

Nijmegen, Netherlands

Seoul National University Hospital

Seoul, South Korea

Hospital Clínic de Barcelona

Barcelona, Spain

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NCT05906316


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