TB-PRACTECAL: study protocol for a randomised, controlled, open-label, phase II–III trial to evaluate the safety and efficacy of regimens containing bedaquiline and pretomanid for the treatment of adult patients with pulmonary multidrug-resistant tuberculosis

Table 1 Standard of care drugs and dosing

Drug	Recommended dose by weight
Drug	30–35 kg	36–40 kg	41–45 kg	46–50 kg	51–55 kg	56–60 kg	61–70 kg	>70 kg
Isoniazid (high dose)	By weight, 15 mg/kg. Max 600 mg
Ethambutol	800mg	800mg	800mg	800mg	1200mg	1200mg	1200mg	1200mg
Pyrazinamide (20–30 mg/kg) Max 2000 mg	800 mg	800 mg	1200 mg	1200 mg	1600 mg	1600 mg	1600 mg	2000 mg
Amikacin	500 mg	500 mg	750 mg	750 mg	1000 mg	1000 mg	1000 mg	1000 mg
Levofloxacin	750 mg	750 mg	750 mg	750 mg	1000 mg	1000 mg	1000 mg	1000 mg
Moxifloxacin	400 mg	400 mg	400 mg	400 mg	400 mg	400 mg	400 mg	400 mg
Ethionamide/prothionamide	500 mg	500 mg	500 mg	500 mg	750 mg	750 mg	750 mg	750 mg
Terizidone/cycloserine	By weight (15–20 mg/kg)	750 mg	750 mg	750 mg	750 mg	750 mg	750 mg	750 mg
Para-aminosalicylic acid	4 g	8 g	8 g	8 g	8 g	8 g	8 g	8 g
Clofazimine	100 mg
Linezolid	300 mg	600 mg	600 mg	600 mg	600 mg	600 mg	600 mg	600 mg
Bedaquiline	400mg once daily for 2 weeks then 200mg three times a week
Delamanid	100 mg twice daily
Imipenem/cilastatin	1000 mg imipenem/1000 mg cilastatin every 12 h
Amoxicillin/clavulanate	500/125mg twice daily (ONLY for use in combination with Imipenem / cilastatin, give orally 30min before infusion)

ISSN: 1745-6215