Zoliflodacin effective for treating urogenital, rectal gonococcal infections

Treatment with oral zoliflodacin appears to be effective against uncomplicated urogenital and rectal gonococcal infections but not against pharyngeal infections, according to the results of a phase II trial.

The study included 141 individuals with signs or symptoms of uncomplicated urogenital gonorrhoea or untreated urogenital gonorrhoea or who had had sexual contact in the previous 14 days with a person who had gonorrhoea. Of these, 57 were randomized to receive a single oral dose of zoliflodacin at 2 g (n=57) or 3 g (n=56) or a single 500-mg intramuscular dose of ceftriaxone (n=28).

All participants underwent test of cure within 6±2 days after treatment, followed by a safety visit 31±2 days after treatment. The primary efficacy endpoint of microbiologic cure at urogenital sites occurred in 96 percent of patients in the 2-g zoliflodacin group, 96 percent in the 3-g group and 100 percent in the ceftriaxone group.

Rectal infections were cured in all five participants in the 2-g zoliflodacin group, all seven in the 3-g group, and all three in the ceftriaxone group. Meanwhile, pharyngeal infections were cured in four of eight participants (50 percent), nine of 11 participants (82 percent) and all four participants (100 percent) in the respective groups.

A total of 84 adverse events occurred, 24 of which were in the 2-g zoliflodacin group, 37 in the 3-g group and 23 in the ceftriaxone group. There were 21 adverse events believed to be related to zoliflodacin, most of which were gastrointestinal.

The present data justify further investigation of zoliflodacin in larger, more definitive studies, researchers said. This is especially important because Neisseria gonorrhoeae has developed resistance to every class of antibiotic recommended for treatment, including cephalosporins and macrolides, which highlight the need for the development of new antimicrobial agents.