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

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11130%2F20%3A10410869" target="_blank" >RIV/00216208:11130/20:10410869 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00064211:_____/20:W0000035

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=W9dld-Y4xr" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=W9dld-Y4xr</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.cmi.2019.08.004" target="_blank" >10.1016/j.cmi.2019.08.004</a>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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 &lt;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. Published by Elsevier Ltd. All rights reserved.

Název v anglickém jazyce

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

Popis výsledku anglicky

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 &lt;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. Published by Elsevier Ltd. All rights reserved.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30216 - Dermatology and venereal diseases

Projekt

<a href="/cs/project/NV17-31777A" target="_blank" >NV17-31777A: Validace analýzy metylace promotorů TSG spojených s HPV indukovanou karcinogenezí jako screeningového vyšetření análního karcinomu v rizikové populaci</a><br>

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2020

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Clinical Microbiology and Infection

ISSN

1198-743X

e-ISSN

—

Svazek periodika

26

Číslo periodika v rámci svazku

2

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

6

Strana od-do

207-212

Kód UT WoS článku

000508234200014

EID výsledku v databázi Scopus

2-s2.0-85072020199