A Prospective, Multicenter, Single-arm MAC-PD Cohort: a NTM-NET and ESGMYC Collaborative Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRadboud University Medical Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
Newly diagnosed MAC-PD (primary or recurrent) as per the international NTM guideline that requires three-drug antimycobacterial treatment
Signed and dated informed consent
Disqualifiers
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;
Trial population
Patients with Mycobacterium avium complex pulmonary disease that (MAC-PD) requires guideline-based three-drug antimycobacterial therapy. MAC is the most common causative species of pulmonary NTM infections.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Culture conversion rate
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.
Time frame
6 monthsSecondary outcomes
1
Change in mycobacterial load compared to baseline
Change in acid fast bacilli (AFB) smear determined by auramine staining
Time frame
6 months2
Change in mycobacterial load compared to baseline
Change in time-to-positivity of positive cultures
Time frame
6 months3
Change in symptoms compared to baseline
Change in symptoms as judged by the treating physician
Time frame
6 months4
Adverse drug reactions to antimycobacterial treatment
Adverse drug reactions and the (assumed) causative antimycobacterial drug
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov