. 2013 Aug 2;2(2):123–144. doi: 10.1007/s40121-013-0009-3

Table 5.

Summary of third Phase 2 trial: Study C209 (unpublished data [17])

Study sites	Inclusion criteria for patients	Exclusion criteria	Study design and intervention	Number of MDR patients (BDQ + OBR)	Findings
33 sites in Asia, South Africa, Eastern Europe, South America	Newly and previously diagnosed smear positive patients with either: (a) MDR-TB (39.9%) (b) pre-XDR-TB (18.9%) (c) XDR (15.9%) .	As for Table 3, except patients with HIV with a CD4 count <250 cells/μL were excluded	Single arm study (a) 24 weeks of OBR and BDQ (400 mg daily for 2 weeks then 200 mg 3 times per week), Then, (b) Individualized 18-month to 24-month treatment for MDR-TB.	233 (205^a)	Culture conversion up to 24 weeks (a) Median time to culture conversion, using time-point of 24 weeks: 57 days (b) Culture conversion (mITT^a): 79.5%
Mortality BDQ + OBR (12/205, 5.6%), up to trial reporting cut-off^b Onset of death: median 376 days since last intake of study drug [17]

Study sites

Inclusion criteria for patients

Exclusion criteria

Study design and intervention

Number of MDR patients (BDQ + OBR)

Findings

33 sites in Asia, South Africa, Eastern Europe, South America

Newly and previously diagnosed smear positive patients with either:

(a) MDR-TB (39.9%)

(b) pre-XDR-TB (18.9%)

As for Table 3, except patients with HIV with a CD4 count <250 cells/μL were excluded

Single arm study

(a) 24 weeks of OBR and BDQ (400 mg daily for 2 weeks then 200 mg 3 times per week),

Then,

(b) Individualized 18-month to 24-month treatment for MDR-TB.

233 (205^a)

Culture conversion up to 24 weeks

(a) Median time to culture conversion, using time-point of 24 weeks: 57 days

(b) Culture conversion (mITT^a): 79.5%

Mortality

BDQ + OBR (12/205, 5.6%), up to trial reporting cut-off^b Onset of death: median 376 days since last intake of study drug [17]

BDQ bediquiline, HIV human immunodeficiency virus, MDR multi-drug resistant, mITT modified intention to treat, OBR optimized background regimen, TB tuberculosis, XDR extensively drug resistant

^amITT: Only 205 patients were included in a ‘modified intention to treat analysis’ (excluding DS TB and people with no DST result)

^bThe final study follow-up data has not yet been reported [17]