Early response rates on day 3 based on temperature and acetate tracing sheets or investigators' measurements

Population wound infection typeAcetate tracing sheetsInvestigator measurements
N′aResponse rateb, no. (%c)95% CIdN′aResponse rateb, no. (%c)95% CId
ITT population
    Overall9289 (96.7)90.8–99.39392 (98.9)94.2–100.0
    Wound infection3232 (100.0)89.1–100.03232 (100.0)89.1–100.0
    Abscess3635 (97.2)85.5–99.93737 (100.0)90.5–100.0
    Cellulitis2422 (91.7)73.0–99.02423 (95.8)78.9–99.9
MITT population
    Overall8078 (97.5)91.3–99.78080 (100.0)95.5–100.0
    Wound infection2929 (100.0)88.1–100.02929 (100.0)88.1–100.0
    Abscess2928 (96.6)82.2–99.92929 (100.0)88.1–100.0
    Cellulitis2221 (95.5)77.2–99.92222 (100.0)84.6–100.0
ME population
    Overall7371 (97.3)90.5–99.77373 (100.0)95.1–100.0
    Wound infection2626 (100.0)86.8–100.02626 (100.0)86.8–100.0
    Abscess2928 (96.6)82.2–99.92929 (100.0)88.1–100.0
    Cellulitis1817 (94.4)72.7–99.91818 (100.0)81.5–100.0
  • a N′, the number of patients with the specified infection type who had valid body temperature and lesion assessments at baseline and at the specified time point.

  • b Response rate was defined as the no. (%) of patients with an early response on day 3, as defined by resolution or absence of fever (<38°C) at 3 consecutive recordings within the previous 24 h and cessation of spread of lesion from baseline based on acetate tracing sheets or investigator measurements.

  • c Percentages were calculated using N′ as the denominator.

  • d CI, confidence interval. 95% CIs are exact binomial confidence intervals.