MAC-PD cohort: A Prospective, Multicenter, Single-arm MAC-PD Cohort: a NTM-NET and ESGMYC Collaborative Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed 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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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.
Secondary Outcome Measures
- Change in mycobacterial load compared to baseline [6 months]
Change in acid fast bacilli (AFB) smear determined by auramine staining
- Change in mycobacterial load compared to baseline [6 months]
Change in time-to-positivity of positive cultures
- Change in symptoms compared to baseline [6 months]
Change in symptoms as judged by the treating physician
- Adverse drug reactions to antimycobacterial treatment [6 months]
Adverse drug reactions and the (assumed) causative antimycobacterial drug
- Antimycobacterial treatment adjustments [6 months]
Any change in the antimycobacterial treatment including the reason
- Other treatment adjustments [6 months]
Changes in concomitant medication, supportive care measures or a surgical intervention
Eligibility Criteria
Criteria
Inclusion Criteria:
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Newly diagnosed MAC-PD (primary or recurrent) as per the international NTM guideline that requires three-drug antimycobacterial treatment
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Signed and dated informed consent
Exclusion Criteria:
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The participant is in poor general condition where participation in the study cannot be accepted per discretion of the Investigator
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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
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HIV-infection;
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Cystic fibrosis;
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1 month antibiotic treatment for current MAC infection;
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< 6 months between previous antimycobacterial NTM-PD treatment and antimycobacterial treatment for current MAC-PD
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Disseminated MAC infection;
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Active pulmonary tuberculosis, fungal or nocardial disease requiring treatment;
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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;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Radboud University Medical Center
Investigators
- Principal Investigator: Jakko van Ingen, MSc, PhD, Radboud University Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-13742