This study will compare a single dose of oral solithromycin to the standard of care (intramuscular ceftriaxone plus oral azithromycin) in the treatment of patients with urogenital gonorrhea. A completed open-label Phase 2 study with single doses of solithromycin resulted in 100% microbiological eradication in male and female patients with uncomplicated urogenital gonorrhea.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
264
Unnamed facility
Baltimore, Maryland, United States
Unnamed facility
Cleveland, Ohio, United States
Unnamed facility
Toledo, Ohio, United States
Unnamed facility
Sydney, New South Wales, Australia
Unnamed facility
To assess the eradication rate of Neisseria gonorrhoeae by culture following a single dose of oral solithromycin compared to single-dose intramuscular ceftriaxone plus oral azithromycin in the Microbiological Intent to Treat population.
Time frame: 7 days after treatment
To assess the safety and tolerability of a single oral dose of solithromycin compared to single-dose IM ceftriaxone plus single-dose oral azithromycin in patients with gonorrhea
Adverse event frequency and severity will be compared between patients who received solithromycin and those who received ceftriaxone plus azithromycin
Time frame: 7 days
To compare bacterial eradication rates of N. gonorrhoeae from rectal or pharyngeal cultures following a single dose of oral solithromycin compared to single-dose IM ceftriaxone plus oral azithromycin.
Time frame: 7 days
To assess clearance or persistence of N. gonorrhoeae and Chlamydia trachomatis nucleic acid from male and female genital, pharyngeal and rectal specimens.
Time frame: 21 days after treatment
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Melbourne, Victoria, Australia