DISCOVER 1 & 2 trials

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.

Secondary endpoint

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.

*Patients with creatinine clearance <30 mL/min had their dose adjusted.
Approximately 5% of patients also received a protocol-specified empiric course of treatment with intravenous aztreonam for coverage of Gram-negative pathogens.
8 Boucher HW, et al. N Engl J Med. 2014;370:2169-79.