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Table 2 Detailed information for the individual drug of each arm in the PROSPECT study

From: A pragmatic randomized controlled trial to evaluate the efficacy and safety of an oral short-course regimen including bedaquiline for the treatment of patients with multidrug-resistant tuberculosis in China: study protocol for PROSPECT

Drug

BDQ

LFX

LZD

CS

CFZ

PZA

PTO

BDQ-containing regimen (duration [weeks])

X

(24 to 40)a

X

(40)

X

(≥ 24)

X

(40)

X

(40)

  

Non-BDQ-containing regimen (duration [weeks])

NA

X

(40)

X

(≥ 24)

X

(40)

X

(40)

X

(40)

X

(First 16)

Dosage formulation

Uncoated tablet

Film-coated tablet

Tablet

Capsule

Capsule

Tablet

Enteric-coated tablet

Unit dose strength

100 mg

100 mg and 500 mg

600 mg

250 mg

50 mg

250 mg

100 mg

Dose regimen

400 mg once daily for the first 2 weeks, 200 mg 3 times per week (with at least 48 h between doses) for the remaining weeks (i.e., 22 weeks or 38 weeks in case bedaquiline treatment is extended to 40 weeks)

30–35 kg:

600 mg daily

36–55 kg:

750 mg daily

 > 55 kg:

1000 mg daily

600 mg daily

30–45 kg:

500 mg daily

 > 45 kg:

750 mg daily

100 mg daily

30–35 kg:

1000 mg daily

36–70 kg:

1500 mg daily

 > 70 kg:

2000 mg daily

30–45 kg:

500 mg daily

46–70 kg:

600 mg daily

 > 70 kg:

800 mg daily

  1. aIf a participant is still sputum culture-positive for MTB by week 16, BDQ treatment will be extended from 24 to 40 weeks
  2. NA, not available