Finding the best treatment for lung disease from infection with Mycobacterium abscessus.

Phase 1

• Conditions: Mycobacterium abscessus pulmonary disease; MedDRA version: 20.1Level: PTClassification code 10064789Term: Mycobacterium abscessus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-000050-10-DK
• Lead Sponsor: niversity of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-22
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Intervention Programs Inclusion Criteria
Eligible participants with mixed NTM infections (slow growers + MABS) or with recurrence of MABS infection following completion of previously successful treatment defined as remaining free of positive respiratory cultures for MABS over 12 months post treatment, will be eligible if they met the inclusion criteria listed below:
1.Positive MABS-PD diagnosis meeting all three American Thoracic Society clinical, radiological and microbiological diagnostic criteria for MABS-PD. Defined as;
a.Clinical: Pulmonary symptoms and exclusion of other diagnoses.
b.Radiological: Nodular or cavitary opacities on chest radiograph or a chest high-resolution computed tomography (HRCT) scan showing multifocal bronchiectasis with multiple small nodules.
c.Microbiological: MABS positive culture results from at least two separate expectorated sputum samples, Or;
d.Positive culture results from at least one bronchial wash or lavage, Or;
e.Transbronchial or other lung biopsy with mycobacterial histopathologic features (granulomatous inflammation or acid-fast bacilli (AFB)) and positive culture for NTM or biopsy showing mycobacterial histopathologic features (granulomatous inflammation or AFB) and one or more sputum or bronchial washes that are culture positive for NTM.
2.Male or female participants in Denmark aged 18 years and older, in other countries children are included.
3.Participant has not received treatment for MABS-PD in the 12 months preceding assessment of eligibility.
4.Informed consent signed by participant or parent/legal guardian if participant is under 18 years of age.
5.Ability to comply with study visits, therapies and study procedures as judged by the site investigator.
Observational Cohort Inclusion Criteria
1-Male and female participants of any age with at least one positive respiratory culture for MABS.
2- Informed consent signed by participant or parent/legal guardian if participant is under 18 years of age.
3-Ability to comply with study visits and study procedures as judged by the site investigator. Potential participants are eligible for the Intervention program (above) if the criteria below
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

Intervention Program participants
•Pregnant or breastfeeding
•QTc interval >500 milliseconds
•Received active treatment for MABS in the previous 12 months, except use of azithromycin as part of routine treatment for CF and bronchiectasis, will be excluded from the trial.

Observational Cohort participants
•Received active treatment for MABS in the previous 12 months, except use of azithromycin as part of routine treatment for CF and bronchiectasis, will be excluded from the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified