Innovation Pharmaceuticals Inc (IPIX)

[DrBones]

Primary outcomes are only for 48-72 hours, secondary outcomes are for later dates. I don't think it means we haven't met secondary outcomes.

Primary Outcome Measures:
Early clinical response [ Time Frame: 48-72 hours after first dose of study drug ] [ Designated as safety issue: No ]
The primary efficacy outcome, early clinical response 48-72 hours after the first dose of study drug, will be determined in the ITT population. A subject will be considered a Clinical Success if 1) the lesion area has decreased by =20% compared to baseline and 2) no additional systemic antibacterials that are potentially effective against gram positive organisms have been administered.


Secondary Outcome Measures:
Clinical Response [ Time Frame: Day 7-8; Day 10-14; Day 21-28 ] [ Designated as safety issue: No ]
For Days 7/8 and 10-14, a response of Clinical Success will be assigned if all signs and symptoms of infection present at baseline have improved and/or resolved and no additional antibiotics are considered necessary. Subjects who have a response of Clinical Success at Day 10-14 will be assessed for sustained efficacy at Day 21-28. A response of Sustained Clinical Success will be assigned if all signs and symptoms remain resolved and no additional antibiotics are considered necessary. If signs and symptoms of infection recurred at the original site of infection and require additional antibiotic therapy, a response of Relapse will be assigned.

Microbiological response [ Time Frame: 48-72 hours; Day 7-8; Day 10-14 ] [ Designated as safety issue: No ]
Microbiological responses for those subjects who had a relevant skin pathogen isolated at baseline (MITT and ME populations)