Clinical Trials in Spain / NCT05906316
Recruiting
Observational
A Prospective, Multicenter, Single-arm MAC-PD Cohort: a NTM-NET and ESGMYC Collaborative Study
NCT05906316 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Mycobacterium Avium Complex Pulmonary Disease
Study 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
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;
Primary outcome measure(s)
- Culture conversion rate — 6 months
Conversion from positive cultures at baseline to negative cultures after 6 months of antimycobacterial treatment, defined by three or more negative sputum cultures sampled a month apart or one negative culture from a bronchial lavage.
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| Oregon Science and Health University | Portland | Oregon | Recruiting |
| UZ Leuven | Leuven | Belgium | Recruiting |
| University of Calgary | Calgary | Alberta | Recruiting |
| University Hospital Center Zagreb | Zagreb | Croatia | Recruiting |
| Aarhus University Hospital | Aarhus | Denmark | Recruiting |
| Rasmus Rude Laub | Hellerup | Denmark | Recruiting |
| University Hospital Frankfurt | Frankfurt | Germany | Recruiting |
| Fukujuji Hospital | Tokyo | Japan | Recruiting |
| Radboud University Medical Center | Nijmegen | Netherlands | Recruiting |
| Seoul National University Hospital | Seoul | South Korea | Recruiting |
| Hospital Clínic de Barcelona | Barcelona | Spain | Recruiting |
More Radboud University Medical Center trials in Spain
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05906316 on ClinicalTrials.gov ↗ ← All trials in Spain