Title

A Multiple Arm, Multiple Stage, Phase 2, OL, Randomized, Controlled Trial to Evaluate 4 Treatment Regimens of SQ109, Increased Doses of Rifampicin, and Moxifloxacin in Adults With Newly Diagnosed, Smear-positive Pulmonary Tuberculosis

Intervention

SQ109 300 mg
Rifampicin 10 to 35 mg/kg
Moxifloxacin 400mg
Isoniazid 75 mg
Pyrazinamide 400 mg
Ethambutol 275 mg

Study Arms

  • Arm 1 (R35): HR35ZE isoniazid, rifampicin 35 mg/kg, pyrazinamide, ethambutol
  • Arm 2 (Q): HRZQ isoniazid, rifampicin standard, pyrazinamide, SQ109 300 mg
  • Arm 3 (R20Q): HR20ZQ isoniazid, rifampicin 20 mg/kg, pyrazinamide, SQ109 300 mg
  • Arm 4 (R20M): HR20ZM isoniazid, rifampicin 20 mg/kg, pyrazinamide, moxifloxacin 400 mg
  • Active Comparator HRZE: Isoniazid, rifampicin standard, pyrazinamide, ethambutol


Primary Outcome Measures

  • Sputum culture conversion (2 negative cultures) using liquid media
  • Time to stable culture conversion (2 consecutive negative weekly cultures) in liquid media.