Table 2– Clinical failure rates at 8 weeks post-therapy
PopulationMoxifloxacinAmoxicillin/clavulanic acid95% CI#p-value
Per protocol111/538 (20.6)114/518 (22.0)−5.89–3.83NA
Intent-to-treat138/677 (20.4)146/675 (21.6)−5.50–3.030.571
Per protocol with pathogens50/260 (19.2)68/261 (26.1)−15.0– −0.750.030
Intent-to-treat with pathogens62/327 (19.0)85/335 (25.4)−13.9– −1.440.016
  • Data are presented as number with clinical failure/total number in population (%), unless otherwise stated. Failures and relapses are included in the failure rate calculation; missing/indeterminates were counted as nonclinical failures in the intent-to-treat populations. NA: not applicable. #: stratified by steroid use and geographical region. : non-inferiority margin 6%, primary analysis designed for non-inferiority only, no superiority tests carried out.