Early Clinical Efficacy

ZINFORO^® may be associated with early clinical response at Day 3¹
 

In a retrospective integrated subgroup analysis of CANVAS 1 and CANVAS 2, ZINFORO^® was associated with a trend towards early clinical response* when compared to vancomycin + aztreonam at Day 3 (P=0.018)^1,†:

Similarly, the Day 3 clinical response rates associated with MRSA infections were^1,†:

This analysis includes the following potential limitations¹:

• Evaluation of an end point that was not pre-specified in the original CANVAS 1 and CANVAS 2 study designs

• Data collection that was not optimised for this outcome measure

• Lack of a pre-specified hypothesis with the corresponding power calculations for this end point¹

Greater improvement on Day 3 was seen regardless of¹:

• ​​​​​​​Age

• Renal function status

• Presence of fever

• Bacteraemia

• Prior antibiotic use

• ​​​​​​​Infection type​​​​​​​

​​​​​​​*ZINFORO® was associated with an early clinical response defined by the cessation of lesion spread and the absence of fever.^1
†Superiority cannot be concluded based on this retrospective integrated analysis because this was not a pre-planned analysis nor was superiority seen in each individual study.

​​CANVAS, CeftAroliNe fosamil versus Vancomycin in Skin and skin structure infection; cSSTI, complicated skin and soft tissue infection; MRSA, methicillin-resistant Staphylococcus aureus.

Reference: