Table 2.
Clinical Response at Early and Late Timepoints
| Timepoint | Dalbavancin Treatment Group |
||
|---|---|---|---|
| Single-Dose, no./No. (%) | 2-Dose, no./No. (%) | Differencea (95% CI) | |
| 48–72 h | |||
| Treatment response (ITT) | 284/349 (81.4) | 294/349 (84.2) | −2.9 (−8.5, 2.8) |
| Treatment nonresponder or indeterminate | 65/349 (18.6) | 55/349 (15.8) | |
| Death | 0 | 1/55 (1.8) | |
| Antibacterial therapy for ABSSSI | 4 /65 (6.2) | 4/55 (7.3) | |
| Decrease of <20% in lesion area | 41/65 (63.1) | 34/55 (61.8) | |
| Missing lesion data | 22/65 (33.8) | 18/55 (32.7) | |
| Lesion area data outside window | 15/65 (23.1) | 11/55 (20.0) | |
| Treatment response (mITT) | 284/349 (81.4) | 294/346 (85.0) | −3.6 (−9.2, 2.0) |
| Treatment response at 36–75 hours (ITT) | 293/349 (84.0) | 298/349 (85.4) | −1.4 (−6.8, 4.0) |
| Day 14 | |||
| Clinical success (ITT) | 293/349 (84.0) | 296/349 (84.8) | −0.9 (−6.3, 4.6) |
| Clinical success (CE) | 267/302 (88.4) | 270/302 (89.4) | −1.0 (−6.1, 4.1) |
| Day 28 | |||
| Clinical success (ITT) | 295/349 (84.5) | 297/349 (85.1) | −0.6 (−6.0, 4.8) |
| Clinical success (CE) | 250/271 (92.3) | 247/267 (92.5) | −0.3 (−4.9, 4.4) |
| Investigator assessment of cure | |||
| Clinical response, day 14 (CE) | 292/302 (96.7) | 292/301 (97.0) | −0.3 (−3.4, 2.7) |
| Clinical response, day 28 (CE) | 263/271 (97.0) | 258/266 (97.0) | 0.1 (−3.1, 3.2) |
Data are presented as No. of patients with the respective observation/No. of patients in the respective population.
Abbreviations: ABSSSI, acute bacterial skin and skin structure infection; CE, clinically evaluable; CI, confidence interval; ITT, intent to treat; mITT, modified intent-to-treat.
a For the difference in clinical response rates (single-dose group minus 2-dose group).