F Rob1, B Klubalová2, E Nyčová3, J Hercogová2, M Unemo4. 1. Dermatovenereology Department, Second Medical Faculty, Charles University, Na Bulovce Hospital, Prague, Czech Republic. Electronic address: filip.rob@gmail.com. 2. Dermatovenereology Department, Second Medical Faculty, Charles University, Na Bulovce Hospital, Prague, Czech Republic. 3. Department of Microbiology, Na Bulovce Hospital, Prague, Czech Republic. 4. World Health Organization Collaborating Centre for Gonorrhoea and Other STIs, Department of Laboratory Medicine, Microbiology, Faculty of Medicine of Health, Örebro University, Örebro, Sweden.
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.
RCT Entities:
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.
Authors: Mitch Matoga; Jane S Chen; Robert Krysiak; Beatrice Ndalama; Cecilia Massa; Naomi Bonongwe; Esther Mathiya; Blessing Kamtambe; Edward Jere; Tarsizio Chikaonda; Daniel Golparian; Magnus Unemo; Myron S Cohen; Marcia M Hobbs; Irving F Hoffman Journal: Sex Transm Dis Date: 2022-04-01 Impact factor: 2.830
Authors: Qibin Duan; Chris Carmody; Basil Donovan; Rebecca J Guy; Ben B Hui; John M Kaldor; Monica M Lahra; Matthew G Law; David A Lewis; Michael Maley; Skye McGregor; Anna McNulty; Christine Selvey; David J Templeton; David M Whiley; David G Regan; James G Wood Journal: PLoS Comput Biol Date: 2021-11-04 Impact factor: 4.475