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.