Mycobacterium Avium Complex Pulmonary Disease
Conditions
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.
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.
Interventions
None listed
Sponsors
Radboud University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in mycobacterial load compared to baseline | 6 months | Change in acid fast bacilli (AFB) smear determined by auramine staining |
| 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 |
Countries
Belgium, Canada, Croatia, Denmark, Germany, Japan, Netherlands, South Korea, Spain, United States
Contacts
CONTACTArthur Lemson, MSc
CONTACTWouter Hoefsloot, MSc, PhD
PRINCIPAL_INVESTIGATORJakko van Ingen, MSc, PhD
Radboud University Medical Center
Outcome results
None listed