FORMaT trial therapy regimens


 

Intensive Therapy Dosing Regimen

Intensive Arm A Intensive Arm B Intensive Arm C
  1. IV amikacin, and;
  2. IV tigecycline, and;
  3. IV imipenem/cefoxitin, and;
  4. Oral azithromycin or oral clarithromycin, and;
  5. Clofazimine
  1. Inhaled amikacin, and;
  2. IV tigecycline, and;
  3. IV imipenem/cefoxitin, and;
  4. Oral azithromycin or oral clarithromycin, and;
  5. Clofazimine
  1. IV amikacin, and;
  2. IV tigecycline, and;
  3. IV imipenem/cefoxitin, and;
  4. Oral azithromycin/clarithromycin

 

Ethambutol may also be added to the treatment arms for participants with confirmed mixed NTM infections (slow growers + MABS) if required by the treating physician.

 

Consolidation Therapy Dosing Regimen

Consolidation Arm a Consolidation Arm b
  1. Oral clofazimine
  2. Oral azithromycin/clarithromycin, and;
  3. In combination with one to three of the following oral antibiotics:
      • Oral linezolid
      • Oral trimethoprim/sulfamethoxazole (co-trimoxazole)
      • Oral doxycycline
      • Oral moxifloxacin
      • Oral bedaquiline
      • Oral rifabutin
  1. Inhaled amikacin
  2. Oral clofazimine
  3. Oral azithromycin/clarithromycin, and;
  4. In combination with one to three of the following oral antibiotics:
      • Oral linezolid
      • Oral trimethoprim/sulfamethoxazole (co-trimoxazole)
      • Oral doxycycline
      • Oral moxifloxacin
      • Oral bedaquiline
      • Oral rifabutin

     

    Ethambutol may also be added to the treatment arms for participants with confirmed mixed NTM infections (slow growers + MABS) if required by the treating physician.