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) |
Pretomanid treatment group.
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.