ZINFORO® may be associated with early clinical response at Day 41,*
In an integrated retrospective subgroup analysis of FOCUS 1 and FOCUS 2, ZINFORO® had a numerically higher clinical response rate† than ceftriaxone at Day 4.1,‡
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*This was shown not to be statistically significant.
†ZINFORO® may be associated with early clinical response, based on the clinical stability and symptom improvement criteria.1
Clinical stability was defined according to the Infectious Diseases Society of America/American Thoracic Society guidelines as temperature ≤37.8 °C, heart rate ≤100 bpm, respiratory rate ≤24 breaths/min, systolic blood pressure ≥90 mm Hg, oxygen saturation ≥90% and absence of confusion/disorientation.1
Clinical improvement was defined as an improvement of at least 1 of 4 symptoms present at baseline (i.e. cough, dyspnoea, pleuritic chest pain and sputum production) with worsening of none. Patients who did not meet both the clinical stability and clinical improvement criteria or who were considered clinical failures by investigators at the EOT visit in those cases in which the EOT visit occurred on Day 4 were considered non-responders on Day 4.1
‡Superiority cannot be concluded based on this retrospective integrated analysis because this was neither a pre-planned analysis nor a superiority seen in an individual study.
ATS, American Thoracic Society; CAP, community-acquired pneumonia; bpm, beats per minute; EOT, end of treatment; FOCUS, ceFtarOline Community-acquired pneUmonia trial versuS ceftriaxone in hospitalised patients; IDSA, Infectious Diseases Society of America; RR, respiratory rate.
Reference:
Safety profile consistent with other cephalosporins
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