78.3%)
-1.5% (-7.4, 4.6)
1 There were 7 patients who did not receive treatment and were counted as non-responders: 6 dalbavancin patients (3 in each trial) and one vancomycin/linezolid patient in Trial 2.
2 Patients who died or used non-study antibacterial therapy or had missing measurements were classified as non-responders.
3 The 95% Confidence Interval (CI) is computed using the Miettinen and Nurminen approach, stratified by baseline fever status.
The specific infections in these trials included cellulitis (approximately 50% of patients across treatment groups), major abscess (approximately 30%), and wound infection (approximately 20%). The median lesion area at baseline was 341 cm2. In addition to local signs and symptoms of infection, patients were also required to have at least one systemic sign of disease at baseline, defined as temperature 38°C or higher (approximately 85% of patients), white blood cell count greater than 12,000 cells/mm3 (approximately 40%), or 10% or more band forms on white blood cell differential (approximately 23%). Across both trials, 59% of patients were from Eastern Europe and 36% of patients were from North America. Approximately 89% of patients were Caucasian and 58% were males. The mean age was 50 years and the mean body mass index was 29.1 kg/m2.
The primary endpoint of these two ABSSSI trials was the clinical response rate where responders were defined as patients who had no increase from baseline in lesion area 48 to 72 hours after initiation of therapy, and had a temperature consistently at or below 37.6° C upon repeated measurement. Table 6 summarizes overall clinical response rates in these two ABSSSI trials using the pre‑specified primary efficacy endpoint in the ITT population.
Table 7. Patients in ABSSSI Trials with Reduction in Lesion Area of 20% or Greater at 48-72 Hours after Initiation of Therapy DALVANCE
n/N (%)
Vancomycin/Linezolid
n/N (%)
Difference
(95%CI)3
Trial 1
259/288 (89.9%)
259/285 (90.9%)
-1.0% (-5.7, 4.0)
Trial 2
325/371 (87.6%)
316/368 (85.9%)
1.7% (-3.2, 6.7)
1 There were 7 patients (as described in Table 6) who did not receive treatment and were counted as non-responders.
2 Patients who died or used non-study antibacterial therapy or had missing measurements were classified as non-responders.
3 The 95% CI is computed using the Miettinen and Nurminen approach, stratified by baseline fever status.
Another secondary endpoint in these two ABSSSI trials was the clinical success rate assessed at a follow-up visit occurring between Days 26 to 30. Clinical Success at this visit was defined as having a decrease in lesion size (both length and width measurements), a temperature of 37.6° C or lower, and meeting pre-specified criteria for local signs: purulent discharge and drainage absent or mild and improved from baseline, heat/warmth & fluctuance absent, swelling/induration & tenderness to palpation absent or mild. Table 8 summarizes clinical success rates at a follow-up visit for the ITT and clinically eva luable population in these two ABSSSI trials. Note that there are insufficient historical data to establish the magnitude of drug effect for antibacterial drugs compared with placebo at the follow-up visits. Therefore, compari |
