Taylor SN, et al. – In this phase 2 trial, researchers assessed zoliflodacin, a new antibiotic that inhibits DNA biosynthesis, for the treatment of uncomplicated gonorrhea. Findings revealed efficacy of oral zoliflodacin for successfully treating the majority of uncomplicated urogenital and rectal gonococcal infections; however, this agent showed less efficacy as a treatment option for pharyngeal infections.

Methods

• Study participants eligible men and women who had signs or symptoms of uncomplicated urogenital gonorrhea or untreated urogenital gonorrhea or who had had sexual contact in the preceding 14 days with a person who had gonorrhea.
• A single oral dose of zoliflodacin (2 g or 3 g) or a single 500-mg intramuscular dose of ceftriaxone in a ratio of approximately 70:70:40 was randomly administered to participants.
• Within 6 ± 2 days after treatment, a test of cure occurred.
• A safety visit was carried out 31 ± 2 days after treatment.
• The proportion of urogenital microbiologic cure was assessed in the microbiologic intention-to-treat (micro-ITT) population.

Results

• A total of 179 participants were enrolled from November 2014 through December 2015.
• In 96% of participants who received 2 g of zoliflodacin, 96% who received 3 g of zoliflodacin, and 100% who received ceftriaxone, researchers noted microbiologic cure at urogenital sites among 141 participants in the micro-ITT population who could be assessed.
• In all five participants who received 2 g of zoliflodacin, all seven who received 3 g, and in all three participants in the group that received ceftriaxone, cure of all rectal infections was documented.
• Findings showed cure of pharyngeal infections in 50% of the participants in the group that received 2 g of zoliflodacin, in 82% of those in the group that received 3 g of zoliflodacin, and in 100% of the group treated with ceftriaxone.
• Data showed 84 documented adverse events: 24 in the group that received 2 g of zoliflodacin, 37 in the group that received 3 g of zoliflodacin, and 23 in the group that received ceftriaxone.
• A total of 21 adverse events were thought to be associated with zoliflodacin, of which most were gastrointestinal in nature.