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RANDOMIZED CLINICAL TRIAL COMPARING GENTAMICIN plus AZITHROMYCIN VS. CEFTRIAXONE plus AZITHROMYCIN FOR RECTAL AND PHARYNGEAL GONORRHEA
Second Medical Faculty Charles University, Na Bulovce Hospital, Dermatovenerology, Prague, Czech Republic.
Second Medical Faculty Charles University, Na Bulovce Hospital, Dermatovenerology, Prague, Czech Republic.
Second Medical Faculty Charles University, Na Bulovce Hospital, Dermatovenerology, Prague, Czech Republic.
Örebro universitet, Institutionen för medicinska vetenskaper. Region Örebro län. World Health Organization Collaborating Centre for Gonorrhoea and Other STIs, Faculty of Medicine of Health, Örebro University, Department of Laboratory Medicine, Microbiology, Örebro, Sweden.ORCID-id: 0000-0003-1710-2081
2019 (Engelska)Ingår i: Sexually Transmitted Infections, ISSN 1368-4973, E-ISSN 1472-3263, Vol. 95, nr Suppl. 1, s. A286-A287Artikel i tidskrift, Meeting abstract (Övrigt vetenskapligt) Published
Abstract [en]

Background: Dual therapy including ceftriaxone plus azithromycin is currently the recommended first-line gonorrhea treatment internationally. However, for gonorrhea cases where ceftriaxone or other extended-spectrum cephalosporin can not be administered (e.g., cephalosporin resistance, allergy, or unavailability), the therapeutic options are very limited. In a previous randomized controlled clinical trial (RCT) by Kirk-caldy et al. (Clin Infect Dis. 2014), gentamicin 240 mg plus azithromycin 2 g showed 100% microbiological cure for uncomplicated gonorrhoea. However, only 10 pharyngeal infections and one rectal infection were examined. We further evaluated the efficacy and tolerability of gentamicin+azithroomycin for treatment of uncomplicated rectal and pharyngeal gonorrhea.

Methods: A non-inferiority, open-label, single center RCT was conducted in Prague, Czech Republic. Patients, 18–75 years of age, diagnosed with uncomplicated rectal or pharyngeal gonorrhea by nucleic acid amplification test (NAAT) (GeneProof®) 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 out-come was negative culture and negative NAAT, i.e., one week and three weeks, respectively, after treatment.

Results: Both clinical and microbiological cure was achieved by 100% of patients in the gentamicin+azithromycin arm (n=68; 40 rectal, 14 pharyngeal, and 14 infections in both localizations) and ceftriaxone+azithromycin arm (n=66; 36 rectal, 14 pharyngeal, and 16 infections in both localizations). Administration of gentamicin was significantly less painful than ceftriaxone according to the visual analog score (p<0.001). Gastrointestinal adverse events were slightly more common in ceftriaxone arm (50.0%) than in gentamicin arm (41.2%), but in most (64%) cases they were mild.

Conclusion: Both gentamicin+azithromycin and ceftriaxone+azithromycin were 100% effective for treatment of rectal and pharyngeal gonorrhea. Gentamicin 240 mg plus azithromycin 2 g appears to be an effective alternative for treatment of both urogenital and extragenital gonorrhea in case of ceftriaxone resistance, allergy, or unavailability.

Ort, förlag, år, upplaga, sidor
BMJ Publishing Group Ltd, 2019. Vol. 95, nr Suppl. 1, s. A286-A287
Nationell ämneskategori
Infektionsmedicin
Identifikatorer
URN: urn:nbn:se:oru:diva-79393DOI: 10.1136/sextrans-2019-sti.718ISI: 000506050104044OAI: oai:DiVA.org:oru-79393DiVA, id: diva2:1388708
Tillgänglig från: 2020-01-27 Skapad: 2020-01-27 Senast uppdaterad: 2020-12-01Bibliografiskt granskad

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