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

Radboud University Medical Center

Status: Enrolling

Conditions: Mycobacterium Avium Complex Pulmonary Disease

Study type: Observational

Funder types: Other

Identifiers

NCT05906316

2022-13742

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;