To Örebro University

OBJECTIVES: To evaluate the efficacy and tolerability of single-dose oral cefixime 800 mg plus oral doxycycline 100 mg b.i.d. for 7 days, compared to recommended single-dose ceftriaxone plus single-dose, oral azithromycin, for treatment of uncomplicated urogenital, rectal or pharyngeal gonorrhoea.

METHODS: A non-inferiority, open-label, multicentre randomised controlled trial was conducted in Prague, Czech Republic. Some 161 patients, 18-65 years of age diagnosed with uncomplicated urogenital, rectal or pharyngeal gonorrhoea by nucleic acid amplification test (NAAT) were randomised to treatment with single-dose cefixime 800 mg plus doxycycline 100 mg b.i.d. for 1 week or single-dose ceftriaxone 1 g intramuscularly plus single-dose azithromycin 2 g. The primary outcome was the number of participants with negative culture and NAAT at 1 week and 3 weeks, respectively, after treatment initiation.

RESULTS: In all, 161 patients were randomised, 152 were included in per-protocol analyses. All 76 (100%; 95% confidence interval [CI], 0.95-1.00) patients treated with ceftriaxone plus azithromycin achieved negative cultures and NAAT after treatment. In the cefixime plus doxycycline arm at week 1, culture was negative in all 76 (100%) patients; at week 3, culture was negative in 70/76 patients (92%; 95%CI, 0.84-0.97) and NAAT negative in 66/76 patients (87%; 95%CI, 0.77-0.94). At week 3, culture and NAAT were negative in 65/76 patients (86%; 95%CI, 0.76-0.93). Per-protocol risk difference was 14.5% (95%CI, 6.56-22.38). All treatment failures observed in the cefixime arm were pharyngeal gonorrhoea cases.

CONCLUSION: The combination of cefixime and doxycycline did not achieve non-inferiority to ceftriaxone and azithromycin for treatment of gonorrhoea when including pharyngeal gonorrhoea. It did, however, show high efficacy for urogenital and rectal gonorrhoea.