A phase 3 open-label trial at 17 clinics in five countries including Thailand randomized people aged 12+ with suspected uncomplicated urogenital gonorrhoea 2:1 to single oral zoliflodacin 3 g (621) or IM ceftriaxone 500 mg plus oral azithromycin 1 g (309). Day 6±2 microbiological cure in microbiological ITT was 90.9% (460/506) versus 96.2% (229/238). The comparator-minus-zoliflodacin difference was 5.3%, with upper 95% CI 8.6%, below the 12% margin. Events were mostly mild/moderate and no serious events occurred.
Key findings
- N=930; cure 90.9% vs 96.2%; difference 5.3%, 95% CI 1.4-8.6 below 12% margin; similar safety; no serious events; single oral dose avoids injection.
Why this matters globally
A new-mechanism oral drug expands options and stewardship as ceftriaxone resistance threatens, but deployment needs susceptibility surveillance to preserve effectiveness.
Thai researcher contribution
Rossaphorn Kittiyaowamarn and Nittaya Phanuphak of Thailand's Ministry of Public Health and HIV-NAT participated in the five-country clinical network.
Limitations to consider
Open label despite masked labs; a 12% margin permits some lower cure. Participants were 88% male and the primary endpoint urogenital, limiting pharyngeal, rectal, female and adolescent conclusions. Short follow-up cannot establish population resistance evolution.