A Prospective, Multicenter, Single-arm MAC-PD Cohort: a NTM-NET and ESGMYC Collaborative Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Mycobacterium Avium Complex Pulmonary Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Belgium, Canada, Croatia, Denmark +5
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Culture conversion rate [Time frame: 6 months]
Secondary outcome measures (6)
- Change in mycobacterial load compared to baseline [Time frame: 6 months]
- Change in mycobacterial load compared to baseline [Time frame: 6 months]
- Change in symptoms compared to baseline [Time frame: 6 months]
- Adverse drug reactions to antimycobacterial treatment [Time frame: 6 months]
- Antimycobacterial treatment adjustments [Time frame: 6 months]
- Other treatment adjustments [Time frame: 6 months]
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 2 centers
- Aarhus University Hospital — Aarhus
- Rasmus Rude Laub — Hellerup
United States · 1 center
- Oregon Science and Health University — Portland
Belgium · 1 center
- UZ Leuven — Leuven
Canada · 1 center
- University of Calgary — Calgary
Croatia · 1 center
- University Hospital Center Zagreb — Zagreb
Germany · 1 center
- University Hospital Frankfurt — Frankfurt
Japan · 1 center
- Fukujuji Hospital — Tokyo
Netherlands · 1 center
- Radboud University Medical Center — Nijmegen
South Korea · 1 center
- Seoul National University Hospital — Seoul
Spain · 1 center
- Hospital Clínic de Barcelona — Barcelona
Identifiers
NCT: NCT05906316 · 2022-13742