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Gentamicin 240 mg plus azithromycin 2 g vs. ceftriaxone 500 mg plus azithromycin 2 g for treatment of rectal and pharyngeal gonorrhoea: a randomized controlled trial

F Rob, B Klubalová, E Nyčová, J Hercogová, M Unemo
Clinical Microbiology and Infection 2019 August 14

OBJECTIVES: To evaluate the efficacy and tolerability of gentamicin 240 mg plus azithromycin 2 g for treatment of uncomplicated rectal and pharyngeal gonorrhoea compared to ceftriaxone 500 mg plus azithromycin 2 g, the recommended European first-line gonorrhoea treatment.

METHODS: A non-inferiority, open-label, single centre randomized controlled trial was conducted in Prague, Czech Republic. Patients, 18-75 years of age, diagnosed with uncomplicated rectal or pharyngeal gonorrhoea by nucleic acid amplification test (NAAT) were randomized to treatment with gentamicin 240 mg intramuscularly plus azithromycin 2 g orally or ceftriaxone 500 g intramuscularly plus azithromycin 2 g orally. The primary outcome was negative culture and negative NAAT, i.e., one week and three weeks, respectively, after treatment.

RESULTS: Both clinical cure and microbiological clearance was achieved by 100% (95%CI 0.95-1.00) of patients in the gentamicin/azithromycin arm (n=72; 40 rectal, 17 pharyngeal, and 15 rectal+pharyngeal infections both localizations) and 100% (95%CI 0.95-1.00) in ceftriaxone/azithromycin arm (n=71; 38 rectal, 14 pharyngeal, and 19 rectal+pharyngeal infections). The absolute difference between the two arms was 0.0% (CI95% -5.1 to 5.1), thus less than the pre-specified margin of 7%. Administration of gentamicin was not more painful than ceftriaxone according to the visual analog scale (1.8 vs. 3.4; p<0.001). Gastrointestinal adverse events were similar in the ceftriaxone arm (33/71, 46.5%) and the gentamicin arm (29/72, 40.3%), and overall in most (52/62, 83.9%) cases they were mild.

CONCLUSIONS: Gentamicin 240 mg plus azithromycin 2 g is an effective alternative for treatment of extragenital gonorrhoea.


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