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Recruiting NCT05906316

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

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Trial Parameters

Condition Mycobacterium Avium Complex Pulmonary Disease
Sponsor Radboud University Medical Center
Study Type OBSERVATIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-07-01
Completion 2026-01-01

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Brief 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 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

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