Xydalba for infections of the skin compared with vancomycin at an early response
Two-dose studies design
Two multicentre, randomised, double-blind, double-dummy, noninferiority trials of similar design with an active comparator (vancomycin/linezolid)1,3
The ITT population included 1312 randomized adult patients* with documented ABSSSI.
Patient selection criteria: patients with cellulitis, abscess, or wound infection with a lesion size ≥75 cm2 and at least one systemic sign of disease at baseline, defined as1:
Temperature ≥38 °C (100.4 °F)
Elevated WBC count (>12,000 cells/mm3)
Or 10% or more band forms on WBC differential
Primary endpoint: early clinical response
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.
This key secondary endpoint evaluated the percentage of ITT patients achieving a 20% or greater reduction in lesion area from baseline at 48 to 72 hours after initiation of therapy.