The incidence rate of gonorrhea increases In France for a few years, in both sexes and all age groups (see opposite). However, its treatment has changed little for three decades, no new antibiotic having proven itself in this indication since the arrival of third generation cephalosporins (Ceftriaxone and Céfixime) in the 1990s. However, the latter face antibiotic resistance – Like previously used antibiotics – which has increased since the 2000s. More than a quarter of patients are resistant to ceftriaxone in certain Asian regions!
A new hope recently appeared: in 2024, A pioneer antibiotic in its class, gepotidacinewas successfully tested against uncomplicated urinary tract infections in two large randomized phase III randomized trials. This bactericidal product is a triazaacenaphylene, a molecule which prevents bacterial replication by A unique action mechanism inhibiting gyrase and top-isomerase IV. It was authorized by the American Food and Drug Administration at the end of March for urinary tract infections excluding those by Neisseria gonorrhoeae.
To test the effectiveness of this new antibiotic in Gonorrhea, American researchers have therefore rose A multicenter phase III testopen and non-inferiority, in order to compare gepotidacin to a standard treatment of gonorrhea (ceftriaxone + azithromycin). The test took place in 49 centers of six countries (Australia, Germany, Mexico, Spain, United States and United Kingdom). Eligible patients had to be over 12 years old, weigh more than 45 kg and have a positive test for N. gonorrhoeae or a suspicion of uncomplicated urogenital gonorrhea.
-Between October 2019 and October 2023, 628 participants were randomized according to a 1: 1 – 1 – and after sex stratio at birth, sexual orientation and age group – in two groups: oral gepotidacin (2 × 3,000 mg at 10 – 12 h of interval) or 500 mg of intramuscular ceftriaxone + 1 g of oral azithromycin. The main judgment criterion was the eradication confirmed by culture of N. gonorrhoeae
of the urogenital zone 4 to 8 days after antibiotic therapyevaluated in patients with confirmed infection to N. gonorrhoeae sensitive to the cetraticaone.
The results published in mid-April in The Lancet : 406 of the 628 participants were part of the population with an infection confirmed by N. gonorrhoeae Sensitive to ceftriaxone (202 people in the gepotidacine arm, 204 in the other arm). Among these 406 people, 92 % were men (71 % of whom had sex with other men [HSH]), 74 % were white and 15 % were black. The eradication test a few days after antibiotic therapy gave non-inferior results in the gepotidacine group Compared to the other group. The gepotidacine arm had a higher rate of undesirable effects, but they were mainly gastrointestinal in nature and low to moderate intensity.
According to the authors, these results show that gepotidacine is a new therapeutic option for uncomplicated urogenital gonorrhea.