drugset
drugset / Trial / NCT07485010

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

NCT07485010 ↗

Phase 2 Not yet recruiting 300 enrolled The University of Queensland Innoviva Specialty Therapeutics · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2027-04
Primary completion
2031-04
Completion
2031-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Amikacin Small molecule 5 mg/kg Intravenous
Subject Amikacin Small molecule 7.5 mg/kg Intravenous
Subject Amikacin Small molecule 15 mg/kg Intravenous
Subject Amikacin Small molecule 20 mg/kg Intravenous
Subject Amikacin Small molecule 25 mg/kg Intravenous
Subject Amikacin Small molecule 30 mg/kg Intravenous
Subject Amikacin Small molecule 500 mg Inhaled
Subject Amoxicillin Other / unclassified 1000 mg Oral
Subject Azithromycin Small molecule 250 mg Oral
Subject Azithromycin Small molecule 500 mg Oral
Subject Bedaquiline Small molecule 400 mg Oral
Subject Cefoxitin Small molecule 50 mg/kg Intravenous
Subject Cefoxitin Small molecule 200 mg/kg Intravenous
Subject Ceftriaxone Other / unclassified 1 g Intravenous
Subject Clarithromycin Small molecule 500 mg Oral
Subject Clofazimine Small molecule 100 mg Oral
Subject Clofazimine Small molecule 300 mg Oral
Subject Doxycycline Small molecule 100 mg Oral
Subject Ethambutol Small molecule 15 mg/kg Oral
Subject Ethambutol Small molecule 25 mg/kg Oral
Subject Imipenem + Cilastatin Unknown 15 mg/kg Intravenous
Subject Imipenem + Cilastatin Unknown 25 mg/kg Intravenous
Subject Imipenem + Cilastatin Unknown 500 mg Intravenous
Subject Linezolid Other / unclassified 600 mg Oral
Subject Moxifloxacin Small molecule 10 mg/kg Oral
Subject Moxifloxacin Small molecule 15 mg/kg Oral
Subject Moxifloxacin Small molecule 400 mg Oral
Subject Rifabutin Small molecule 5 mg/kg Oral
Subject Sulbactam-durlobactam Unknown 25 mg/kg Intravenous
Subject Tigecycline Small molecule 0.6 mg/kg Intravenous
Subject Tigecycline Small molecule 1.2 mg/kg Intravenous
Subject Tigecycline Small molecule 50 mg Intravenous
Subject Trimethoprim / Sulfamethoxazole Unknown 160 mg Oral
Subject Trimethoprim / Sulfamethoxazole Unknown 800 mg Oral

Indications

pulmonary non-tuberculous mycobacterial infection