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  • Bížová, B.Dermatovenereology Department, Second Faculty of Medicine, Charles University, University Hospital Bulovka, Prague, Czech Republic (author)

Single-dose cefixime 800 mg plus doxycycline 100 mg b.i.d. for 7 days compared to single-dose ceftriaxone 1 g plus single-dose azithromycin 2 g for treatment of urogenital, rectal and pharyngeal gonorrhoea : A randomised clinical trial

  • Article/chapterEnglish2024

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  • European Society of Clinical Microbiology and Infectious Diseases (ESCMID),2024
  • printrdacarrier

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  • LIBRIS-ID:oai:DiVA.org:oru-109807
  • https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-109807URI
  • https://doi.org/10.1016/j.cmi.2023.11.006DOI

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  • Language:English
  • Summary in:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

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  • 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.

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  • Procházka, P.Venereology Prague, Medicentrum Beroun, Prague, Czech Republic (author)
  • Nyčová, E.Department of Microbiology, University Hospital Bulovka, Prague, Czech Republic (author)
  • Bořil, P.Clinical Laboratory, Medicentrum Beroun, Beroun, Czech Republic (author)
  • Kubele, J.Clinical Microbiology and ATB centre, Na Homolce Hospital, Prague, Czech Republic (author)
  • Poláková, A.Department of Microbiology, University Hospital Bulovka, Prague, Czech Republic (author)
  • Zemanová, Z.Clinical Microbiology and ATB centre, Na Homolce Hospital, Prague, Czech Republic (author)
  • Unemo, Magnus,1970-Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,World Health Organization Collaborating Centre for Gonorrhoea and Other STIs, Department of Laboratory Medicine, Microbiology, Faculty of Medicine of Health, Örebro University, Örebro, Sweden; Institute for Global Health, University College London, London, United Kingdom(Swepub:oru)muo (author)
  • Rob, F.Dermatovenereology Department, Second Faculty of Medicine, Charles University, University Hospital Bulovka, Prague, Czech Republic (author)
  • Dermatovenereology Department, Second Faculty of Medicine, Charles University, University Hospital Bulovka, Prague, Czech RepublicVenereology Prague, Medicentrum Beroun, Prague, Czech Republic (creator_code:org_t)

Related titles

  • In:Clinical Microbiology and Infection: European Society of Clinical Microbiology and Infectious Diseases (ESCMID)30:2, s. 211-2151198-743X1469-0691

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