drugset
drugset / Trial / NCT04310930

Finding the Optimal Regimen for Mycobacterium Abscessus Treatment

NCT04310930 ↗

Phase 2/3 Recruiting 300 enrolled The University of Queensland Australian Government Department of Health and Ageing · collabChildren's Hospital Foundation · collabCystic Fibrosis Foundation · collabErasmus Medical Center · collabGriffith University · collabMonash University · collabMurdoch Childrens Research Institute · collabNewcastle University · collabQIMR Berghofer Medical Research Institute · collabSouth Australian Health and Medical Research Institute · collabUniversity of Copenhagen · collabUniversity of Melbourne · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Mycobacterium abscessus (MABS) is a group of rapid-growing, multi-drug resistant non-tuberculous mycobacteria (NTM) causing infections in humans. MABS pulmonary disease (MABS-PD) can result in significant morbidity, increased healthcare utilisation, accelerated lung function decline, impaired quality of life, more challenging lung transplantation, and increased mortality. While the overall numbers affected is small, the prevalence of infections is increasing worldwide. The Finding the Optimal Regimen for Mycobacterium abscessus Treatment (FORMaT) trial aims to produce high quality evidence for the best treatment regimens to maximise health outcomes and minimise toxicity and treatment burden, as well as developing biomarkers (serology, gene expression signatures, and radiology) to guide decisions for starting treatment and measuring disease severity in patients with MABS PD.

Timeline

Start
2020-03-02
Primary completion
2029-06-30
Completion
2030-06-30

Publications

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 Intravenous
Subject Azithromycin Small molecule 10 mg/kg 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 Clarithromycin Small molecule 7.5 mg/kg Oral
Subject Clarithromycin Small molecule 62.5 mg Oral
Subject Clarithromycin Small molecule 125 mg Oral
Subject Clarithromycin Small molecule 187.5 mg Oral
Subject Clarithromycin Small molecule 250 mg Oral
Subject Clarithromycin Small molecule 500 mg Oral
Subject Clofazimine Small molecule 3 mg/kg Oral
Subject Clofazimine Small molecule 5 mg/kg Oral
Subject Clofazimine Small molecule 50 mg Oral
Subject Clofazimine Small molecule 100 mg Oral
Subject Doxycycline Small molecule 2 mg/kg Oral
Subject Doxycycline Small molecule 100 mg Oral
Subject Ethambutol Small molecule 15 mg/kg Oral
Subject Ethambutol Small molecule 20 mg/kg Oral
Subject Ethambutol Small molecule 25 mg/kg Oral
Subject IMIPENEM ANHYDROUS Small molecule 15 mg/kg Intravenous
Subject IMIPENEM ANHYDROUS Small molecule 25 mg/kg Intravenous
Subject IMIPENEM ANHYDROUS Small molecule 500 mg Intravenous
Subject IMIPENEM ANHYDROUS Small molecule 1 g Intravenous
Subject Linezolid Other / unclassified 10 mg/kg Oral
Subject Linezolid Other / unclassified 300 mg Oral
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 Tigecycline Small molecule 1.2 mg/kg Intravenous
Subject Tigecycline Small molecule 50 mg Intravenous
Subject trimethoprim-sulfamethoxazole Unknown 5 mg/kg Oral
Subject trimethoprim-sulfamethoxazole Unknown 160 mg Oral

Indications

pulmonary non-tuberculous mycobacterial infection