The test-of-cure visit evaluating the clinical cure ranged from the end of treatment to 28 days later.
In the test-of-cure assessment, successful berenil mediated cure could be confirmed within 48 h after treatment.
Other trials of outpatient antibiotic therapy for ABSSSIs performed in the ED-setting have used investigator-determined clinical resolution of disease at the test-of-cure visit [9,46-49].
Given that these two trials demonstrated historical evidence of sensitivity to drug effects (HESDE), the FDA recommended this new early primary outcome measure and as a secondary outcome, sustained clinical response at the later test-of-cure visit.
A routine test-of-cure (toc) was recommended one month following azithromycin.
At the test-of-cure visit, 69.7% patients of the tigecyclin group and 78.4% of the imipenem/cilastatin group were clinically cured.
M.genitalium-infection was treated with 1 g of azithromycin and a test-of-cure (toc) was performed one month post-azithromycin.
The test-of-cure for N. gonorrhoeae was not performed.
Clinical responses were graded as cure, failure, or indeterminate at the test-of-cure assessment.
