RECRUITING

A Prospective, Multicenter, Single-arm MAC-PD Cohort: a NTM-NET and ESGMYC Collaborative Study

Talk to us

Conditions

Mycobacterium Avium Complex Pulmonary Disease

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Prospective, Multicenter, Single-arm MAC-PD Cohort: a NTM-NET and ESGMYC Collaborative Study

Quick Facts

Study Start:2023-07-01
Study Completion:2026-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05906316

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Newly diagnosed MAC-PD (primary or recurrent) as per the international NTM guideline that requires three-drug antimycobacterial treatment
  2. * Signed and dated informed consent
  1. * The participant is in poor general condition where participation in the study cannot be accepted per discretion of the Investigator
  2. * 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
  3. * HIV-infection;
  4. * Cystic fibrosis;
  5. * \>1 month antibiotic treatment for current MAC infection;
  6. * \< 6 months between previous antimycobacterial NTM-PD treatment and antimycobacterial treatment for current MAC-PD
  7. * Disseminated MAC infection;
  8. * Active pulmonary tuberculosis, fungal or nocardial disease requiring treatment;
  9. * 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

Study Contact

Arthur Lemson, MSc
CONTACT
+31634265743
arthur.lemson@radboudumc.nl
Wouter Hoefsloot, MSc, PhD
CONTACT
+31611072569
wouter.hoefsloot@radboudumc.nl

Principal Investigator

Jakko van Ingen, MSc, PhD
PRINCIPAL_INVESTIGATOR
Radboud University Medical Center

Study Locations (Sites)

Oregon Science and Health University
Portland, Oregon, 97239
United States

Collaborators and Investigators

Sponsor: Radboud University Medical Center

  • Jakko van Ingen, MSc, PhD, PRINCIPAL_INVESTIGATOR, Radboud University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-01
Study Completion Date2026-07-01

Study Record Updates

Study Start Date2023-07-01
Study Completion Date2026-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Mycobacterium Avium Complex Pulmonary Disease