About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Must not have any exclusion criteria as per the FORMaT Master Protocol and Appendix A1 Exclusion Criteria (NCT04310930).
Participants aged <12 years old.
Participants aged between 12 and <18years old with clinically significant renal impairment as indicated by an age-appropriate estimated creatinine clearance.
Sulbactam/durlobactam
Trial design
Treatments tested in this trial
- Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours)
- Ceftriaxone for Injection
- Amoxicillin
- Azithromcyin
- clarithromycin
- Clofazimine
- Ethambutol
- Amikacin Injection
- tigecycline
- Imipenem + Cilastatin
- Cefoxitin
- Amikacin (Inhalation)
- linezolid
- Trimethoprim / Sulfamethoxazole
- Doxycycline
- moxifloxacin
- bedaquiline
- Rifabutin
Treatment groups
6
Treatment groupsSee each treatment group below.
Locations
Sponsors and collaborators
The University of Queensland
Lead sponsor
Innoviva Specialty Therapeutics
Collaborator