Back to Trials
NCT05906316Recruiting

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

Radboud University Medical Center

Start Date

7/1/2023

Completion Date

7/1/2026

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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;

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Mycobacterium Avium Complex Pulmonary Disease

Locations

Oregon Science and Health University

Portland, Oregon 97239

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, 6511LK

Netherlands

Seoul National University Hospital

Seoul,

South Korea

Hospital Clínic de Barcelona

Barcelona,

Spain