Single dose trial

Xydalba single dose compared with two doses

Single Dose Study Design

  • Phase 3, randomized, double-blind, non-inferiority trial evaluated the efficacy and safety of a single dose of Xydalba vs the two dose Xydalba regimen1
  • The ITT population included 698 randomized adult patients* with documented ABSSSI1
  • 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 as:
    • Temperature ≥38 °C,
    • WBC count >12,000 cells/mm3, or
    • ≥10% band forms on WBC differential

Primary endpoint

Clinical response defined as patients who had at least a 20% decrease from baseline in lesion area 48 to 72 hours after randomization without receiving any rescue antibiotic treatment.

Secondary endpoint

Clinical success rate at follow-up visit (Days 26 to 30) was defined as having at least a 90% decrease from baseline in lesion size, 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 (for patients with wound infections), heat/warmth and fluctuance absent, swelling/induration and tenderness to palpation absent or mild.

*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.
10 MW Dunne et al. Clinical Infectious Diseases. 2016;62(5):545–51