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- Bížová, B., et al.
(author)
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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
- 2024
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In: Clinical Microbiology and Infection. - : European Society of Clinical Microbiology and Infectious Diseases (ESCMID). - 1198-743X .- 1469-0691. ; 30:2, s. 211-215
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Journal article (peer-reviewed)abstract
- 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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| 2. |
- Rob, F., et al.
(author)
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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
- 2020
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In: Clinical Microbiology and Infection. - : Elsevier. - 1198-743X .- 1469-0691. ; 26:2, s. 207-212
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Journal article (peer-reviewed)abstract
- Objectives: The aim was 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. 1 week and 3 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 analogue 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. (C) 2019 European Society of Clinical Microbiology and Infectious Diseases.
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