NCT07485010Not yet recruitingPhase 2
Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial
A Multi-centre, Randomised Trial Comparing a Novel Combination Treatment (Arm D - Intravenous Sulbactam-durlobactam in Combination With Intravenous Ceftriaxone, Oral Amoxicillin, Oral Azithromycin and Oral Clofazimine) Versus Standard of Care Treatments for the Intensive Phase of Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial
Source: ClinicalTrials.gov · Last updated 20 Mar 2026
Brief summary (registry, in English)
The goal of this clinical trial is to learn if a new combination antibiotic treatment (Arm D) works to treat a rare lung condition called mycobacterium abscessus pulmonary disease in people of any age and sex, when compared to the standard treatments. It will also learn about the safety of this new combination antibiotic treatment when compared to the standard treatments. The main questions it aims to answer are: * How well does Arm D treat mycobacterium abscessus pulmonary disease? * What side effects does Arm D cause when used to treat mycobacterium abscessus pulmonary disease? Researchers will compare Arm D to the current standard of care treatments to see if Arm D treats mycobacterium abscessus pulmonary disease better and if it will cause less side effects. Participants will: * Be screened and recruited to the FORMaT adaptive platform trial (NCT04310930) * Be given Arm D for 4 weeks or standard of care treatments for 6 weeks. * Be reviewed by the study doctors weekly for checkups and tests. * Provide respiratory samples (sample coughed up from the chest), respond to quality-of-life questionnaires, have CT lung scans and blood tests.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 12 Mar 2026
- Start date
- 1 Apr 2027
- Primary completion date
- 30 Apr 2031
- Lead sponsor
- The University of Queensland
- Diseases
- Cystic fibrosis
- NCT number
- NCT07485010
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 300
- From 1 Apr 2027 to the primary completion date, 30 Apr 2031
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known hypersensitivity to any of the therapies for which no alternative option(s) have been provided. This includes:
- Sulbactam/durlobactam
- Ceftriaxone,
- Amoxicillin,
- Macrolide antibiotics, and
- Clofazimine.
Lab values
- Participants aged between 12 and \<18years old with clinically significant renal impairment as indicated by an age-appropriate estimated creatinine clearance.
Age
- Participants aged \<12 years old.
Other
- Must not have any exclusion criteria as per the FORMaT Master Protocol and Appendix A1 Exclusion Criteria (NCT04310930).
Who the study is looking for
- Must meet eligibility criteria as per the FORMaT Master Protocol and Appendix A1 Inclusion Criteria (NCT04310930).
- Male or female participants aged 12 years and older.
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.