TABLE 5.
Microbiological response at the posttreatment evaluation visit in patients with a baseline pathogen (safety population)
| Parameter | Data by patient group (omadacycline dose)a: |
||
|---|---|---|---|
| 1 (i.v. 200 mg → p.o. 300 mg [n = 11]) |
2 (p.o. 300 mg [n = 10]) |
3 (p.o. 450 mg [n = 10]) |
|
| Patients with pathogen growth at baseline (N1 [%])b | 6 (54.5) | 5 (50.0) | 7 (70.0) |
| Outcome (n [%])c | |||
| Favorabled | 6 (100.0) | 4 (80.0) | 4 (57.1) |
| Unfavorable | 0 | 1 (20.0) | 3 (42.9) |
| Indeterminate | 0 | 0 | 0 |
a
Omadacycline doses are given in parentheses after each group. i.v., intravenous; p.o., oral.
b
Percentages were calculated as 100 × (N1/N). N1, number of subjects with organism growth at baseline; N, total number of subjects.
c
Favorable indicates that each baseline pathogen was reduced to <104 CFU/ml. Unfavorable indicates that at least one baseline pathogen was not reduced to <104 CFU/ml. Indeterminate indicates that follow-up cultures were not obtained.
d
Percentages were calculated as 100 × (n/N1).