High-dose rifampicin, moxifloxacin, and SQ109 for treating tuberculosis: a multi-arm, multi-stage randomised controlled trial

RCT (n=365) noted that dose of 35 mg/kg rifampicin was safe and reduced the time to culture conversion in liquid media at 12 weeks vs. control group. Researchers suggest this could be promising component of future, shorter regimens.

Experimental treatments, which were given for 12 weeks, followed by 14 weeks of standard dose isoniazid and rifampicin, consisted of

• Rifampicin 35 mg/kg, plus standard dose isoniazid, pyrazinamide, and ethambutol

• Rifampicin 10 mg/kg, standard dose isoniazid and pyrazinamide, and SQ109 (investigational agent) 300 mg

• Rifampicin 20 mg/kg, standard dose isoniazid and pyrazinamide, and SQ109 300 mg

• Rifampicin 20 mg/kg, standard dose isoniazid and pyrazinamide, and moxifloxacin 400 mg

 

Control treatment consisted of standard dose rifampicin (10 mg/kg), isoniazid (5 mg/kg, pyrazinamide (25 mg/kg and ethambutol (15–20 mg/kg) for 8 weeks, followed by 18 weeks of standard dose rifampicin and isoniazid.

 

A commentary notes that phase II trials can be helpful to identify promising regimens, but the intermediate outcome of 2 or 3 months culture conversion requires further validation work, before this outcome can be used to confidently plan phase 3 trials. It adds that it shares the optimism of the investigators of this current study that high dose rifampicin might be useful in shortening current treatment for drug sensitive tuberculosis; but in a more limited dose.