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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Culture conversion rate [Срок оценки: 6 months]

Вторичные конечные точки (6)

• Change in mycobacterial load compared to baseline [Срок оценки: 6 months]
• Change in mycobacterial load compared to baseline [Срок оценки: 6 months]
• Change in symptoms compared to baseline [Срок оценки: 6 months]
• Adverse drug reactions to antimycobacterial treatment [Срок оценки: 6 months]
• Antimycobacterial treatment adjustments [Срок оценки: 6 months]
• Other treatment adjustments [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Newly diagnosed MAC-PD (primary or recurrent) as per the international NTM guideline that requires three-drug antimycobacterial treatment
• Signed and dated informed consent

Критерии исключения

• 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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Дания · 2 центра

• Aarhus University Hospital — Aarhus
• Rasmus Rude Laub — Hellerup

США · 1 центр

• Oregon Science and Health University — Portland

Бельгия · 1 центр

• UZ Leuven — Leuven

Канада · 1 центр

• University of Calgary — Calgary

Хорватия · 1 центр

• University Hospital Center Zagreb — Zagreb

Германия · 1 центр

• University Hospital Frankfurt — Frankfurt

Япония · 1 центр

• Fukujuji Hospital — Tokyo

Нидерланды · 1 центр

• Radboud University Medical Center — Nijmegen

South Korea · 1 центр

• Seoul National University Hospital — Seoul

Испания · 1 центр

• Hospital Clínic de Barcelona — Barcelona

Идентификаторы

NCT: NCT05906316 · 2022-13742

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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