In a multicenter Phase II study, the research team investigated the efficacy of zoliflodacin in the treatment of uncomplicated gonorrhea. The study period was from November 2014 to December 2015. The US study involved 179 subjects, including 167 men and 12 non-pregnant women between the ages of 18 and 55. Participants showed symptoms of uncomplicated urogenital gonorrhea and had sexual intercourse with an infected person over the last 14 days.
Patients were randomized randomized into a ratio of 70:70:40 and treated with oral zoliflodacin at 2 g and 3 g as single dose or single intramuscular injection with 500 mg of ceftriaxone as comparator. After six days, the first check-up took place and another after 31 days. The main measure of effectiveness was microbiological healing in the urogenital area. After six days, 96% (55 out of 57) of subjects treated with 2 g of zoliflodacin were treated with urogenital gonorrhea, 96% (54 of 56) under 3 g of zoliflodacin and 100% (28 of 28) of ceftriaxone.
The 15 subjects with rectal gonorrhea were treated 100% in all arms of the study. Compared to ceftriaxone, the new antibiotic was lower than the treatment of pharyngeal gonorrhea infections. Four out of eight subjects treated with 2 g of zoliflodacin were considered healed. There were 9 participants on 11 between 3 g and all four subjects in the control group with ceftriaxone.