Single-dose cefixime 800 mg plus doxycycline 100 mg twice a day for 7 days compared with single-dose ceftriaxone 1 g plus single-dose azithromycin 2 g for treatment of urogenital, rectal, and pharyngeal gonorrhoea: a randomised clinical trial
Jazyk angličtina Země Anglie, Velká Británie Médium print-electronic
Typ dokumentu hodnocení ekvivalence, časopisecké články, multicentrická studie, randomizované kontrolované studie
PubMed
37981059
DOI
10.1016/j.cmi.2023.11.006
PII: S1198-743X(23)00564-5
Knihovny.cz E-zdroje
- Klíčová slova
- Azithromycin, Cefixime, Ceftriaxone, Doxycycline, Neisseria gonorrhoeae, Treatment,
- MeSH
- antibakteriální látky terapeutické užití MeSH
- azithromycin terapeutické užití MeSH
- cefixim terapeutické užití MeSH
- ceftriaxon * MeSH
- dospělí MeSH
- doxycyklin terapeutické užití MeSH
- gonorea * farmakoterapie mikrobiologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- Neisseria gonorrhoeae MeSH
- senioři MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
- hodnocení ekvivalence MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- antibakteriální látky MeSH
- azithromycin MeSH
- cefixim MeSH
- ceftriaxon * MeSH
- doxycyklin MeSH
OBJECTIVES: To evaluate the efficacy and tolerability of a single dose of oral cefixime 800 mg plus oral doxycycline 100 mg twice a day for 7 days, compared with a recommended single dose of ceftriaxone plus single dose of oral azithromycin, for treatment of uncomplicated urogenital, rectal, or pharyngeal gonorrhoea. METHODS: A noninferiority, open-label, multicentre randomized 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 randomized to treatment with single dose of cefixime 800 mg plus doxycycline 100 mg twice a day for 1 week or a single dose of ceftriaxone 1 g intramuscularly plus single dose of 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 randomized and 152 were included in per-protocol analyses. All 76 (100%; 95% 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 of the 76 patients (92%; 95% CI, 0.84-0.97) and NAAT negative in 66 of the 76 patients (87%; 95% CI, 0.77-0.94). At week 3, culture and NAAT were negative in 65 of the 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. DISCUSSION: The combination of cefixime and doxycycline did not achieve noninferiority to ceftriaxone and azithromycin for treatment of gonorrhoea when including pharyngeal gonorrhoea. It did, however, show high efficacy for urogenital and rectal gonorrhoea.
Clinical Laboratory Medicentrum Beroun Beroun Czech Republic
Clinical Microbiology and ATB Centre Na Homolce Hospital Prague Czech Republic
Department of Microbiology University Hospital Bulovka Prague Czech Republic
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