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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
Dermatovenereology Department, Second Medical Faculty, Charles University, Na Bulovce Hospital, Prague, Czech Republic.
Dermatovenereology Department, Second Medical Faculty, Charles University, Na Bulovce Hospital, Prague, Czech Republic.
Department of Microbiology, Na Bulovce Hospital, Prague, Czech Republic.
Dermatovenereology Department, Second Medical Faculty, Charles University, Na Bulovce Hospital, Prague, Czech Republic.
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2019 (English)In: Clinical Microbiology and Infection, ISSN 1198-743X, E-ISSN 1469-0691Article in journal (Refereed) Epub ahead of print
Abstract [en]

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.

Place, publisher, year, edition, pages
Blackwell Publishing, 2019.
Keywords [en]
Azithromycin, Ceftriaxone, Gentamicin, Neisseria gonorrhoeae, Treatment
National Category
Infectious Medicine
Identifiers
URN: urn:nbn:se:oru:diva-75822DOI: 10.1016/j.cmi.2019.08.004PubMedID: 31419483OAI: oai:DiVA.org:oru-75822DiVA, id: diva2:1345204
Available from: 2019-08-23 Created: 2019-08-23 Last updated: 2019-08-23Bibliographically approved

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Unemo, Magnus

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