Article Text

Download PDFPDF

S08.1 Treatment of Gonorrhoea in an Era of Emerging Cephalosporin Resistance and Results of a Randomised Trial of New Potential Treatment Options
  1. R D Kirkcaldy
  1. CDC, Atlanta, GA, United States


Background Cephalosporins are the mainstay of recommended gonorrhoea treatment, and there is an urgent need for treatment options for cephalosporin-allergic patients or infections with suspected cephalosporin resistance. We evaluated the efficacy and tolerability of two novel combinations of existing antimicrobials for treatment of uncomplicated urogenital gonorrhoea.

Methods We conducted a non-comparative trial, randomising patients with urogenital gonorrhoea to one of two regimens: gentamicin 240 mg intramuscularly plus azithromycin 2 g orally (GENT/AZI), or gemifloxacin 320 mg orally plus azithromycin 2 g orally (GEMI/AZI). The primary outcome was microbiologic cure of urogenital infections (negative follow-up culture) at 10–17 days post-treatment. All participants who returned for follow-up and had evaluable follow-up cultures were included in this per protocol analysis.

Results For 401 evaluable participants (GENT/AZI-202; GEMI/AZI-199), the mean age of both groups was 30 years. Most participants were heterosexual men (GENT/AZI, 57%; GEMI/AZI, 51%), followed by men who have sex with men (GENT/AZI, 33%; GEMI/AZI, 39%), and women (GENT/AZI, 9%; GEMI/AZI, 11%). Microbiological cure was achieved by 100% (lower one-sided 95% confidence interval, 98.5%) of GENT/AZI participants, and 99.5% (lower one-sided 95% confidence interval, 97.6%) of GEMI/AZI participants. GENT/AZI cured 10/10 pharyngeal and 1/1 rectal infections; GEMI/AZI cured 15/15 pharyngeal and 5/5 rectal infections. In the GENT/AZI arm, the most common adverse events (AEs) were mild-moderate nausea (27% of participants), diarrhoea (19%), abdominal discomfort/pain and vomiting (both 7%). In the GEMI/AZI arm, the most common AEs were nausea (37% [8% moderate-severe]), diarrhoea (23%), and abdominal discomfort/pain (11%).

Conclusions Both study regimens were highly effective. Gastrointestinal AEs, especially nausea and diarrhoea, were common. These results provide alternative gonorrhoea treatment options for patients who cannot be treated with cephalosporins.

  • cephalosporin resistance
  • gonorrhea

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.