Skip to main content
. 2019 Nov 21;63(12):e00732-19. doi: 10.1128/AAC.00732-19

TABLE 6.

Observed and PD model-predicted EBA as fall in log10 CFU/ml sputum/day for CL-010 and CL-007

Groupa Mean (SD) value forb :
EBA0–2
EBA2–14
EBA0–14
Obs [n] Pred Obs [n] Pred Obs [n] Pred
CL-010
    50 mg 0.093 (0.211) [14] 0.042 (0.037) 0.059 (0.060) [12] 0.057 (0.046) 0.063 (0.058) [12] 0.055 (0.045)
    100 mg 0.111 (0.332) [15] 0.064 (0.050) 0.088 (0.085) [15] 0.081 (0.059) 0.091 (0.073) [15] 0.079 (0.057)
    150 mg −0.009 (0.290) [15] 0.076 (0.056) 0.096 (0.098) [14] 0.094 (0.065) 0.078 (0.074) [14] 0.091 (0.063)
    200 mg 0.160 (0.255) [14] 0.084 (0.061) 0.104 (0.083) [14] 0.100 (0.068) 0.112 (0.070) [14] 0.099 (0.067)
CL-007
    200 mg 0.109 (0.487) [15] 0.084 (0.061) 0.106 (0.063) [12] 0.100 (0.068) 0.106 (0.049) [12] 0.099 (0.067)
    600 mg 0.096 (0.226) [13] 0.110 (0.073) 0.113 (0.079) [12] 0.120 (0.077) 0.107 (0.053) [14] 0.120 (0.076)
    1,000 mg 0.025 (0.340) [15] 0.110 (0.077) 0.095 (0.062) [14] 0.130 (0.079) 0.091 (0.083) [15] 0.130 (0.078)
    1,200 mg −0.035 (0.420) [15] 0.120 (0.078) 0.113 (0.099) [11] 0.130 (0.080) 0.088 (0.084) [11] 0.130 (0.079)
a

Pretomanid treatment group.

b

The values shown represent the fall in log10 CFU/ml sputum/day during treatment days 0 to 2 (EBA0–2), 2 to 14 (EBA2–14), and 0 to 14 (EBA0–14) in the CL-007 and CL-010 studies. EBA, early bactericidal activity; Obs, observed value; [n], number of participants for observed data; Pred, predicted value (sample size equal to 10,000). Observed values for the CL-007 and CL-010 studies are from references 13 and 14, respectively, by Diacon et al.