NCT05906316

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.

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Jul 2023

Typical duration for all trials

Geographic Reach
10 countries

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jul 2023Jul 2026

First Submitted

Initial submission to the registry

June 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

June 26, 2025

Status Verified

November 1, 2024

Enrollment Period

2.5 years

First QC Date

June 7, 2023

Last Update Submit

June 25, 2025

Conditions

Mycobacterium Avium Complex Pulmonary Disease

Outcome Measures

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.

    6 months

Secondary Outcomes (6)

  • Change in mycobacterial load compared to baseline

    6 months

  • Change in mycobacterial load compared to baseline

    6 months

  • Change in symptoms compared to baseline

    6 months

  • Adverse drug reactions to antimycobacterial treatment

    6 months

  • Antimycobacterial treatment adjustments

    6 months

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • Newly diagnosed MAC-PD (primary or recurrent) as per the international NTM guideline that requires three-drug antimycobacterial treatment
  • Signed and dated informed consent

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Oregon Science and Health University

Portland, Oregon, 97239, United States

RECRUITING

UZ Leuven

Leuven, Belgium

RECRUITING

University of Calgary

Calgary, Alberta, Canada

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, 6511LK, Netherlands

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Hospital Clínic de Barcelona

Barcelona, Spain

RECRUITING

Study Officials

  • Jakko van Ingen, MSc, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arthur Lemson, MSc

CONTACT

+31634265743arthur.lemson@radboudumc.nl

Wouter Hoefsloot, MSc, PhD

CONTACT

+31611072569wouter.hoefsloot@radboudumc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2023

First Posted

June 15, 2023

Study Start

July 1, 2023

Primary Completion

January 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

June 26, 2025

Record last verified: 2024-11

Locations

NL(1)JP(1)ES(1)US(1)CR(1)KR(1)DK(2)CA(1)DE(1)BE(1)