Ertapenem not inferior to ceftriaxone in treating gonorrhea, study finds
February 05, 2022
2 minute read
Disclosures: De Vries does not report any relevant financial information. Please see the study for relevant financial information from all other authors.
A trial that evaluated three alternative treatments for anogenital gonorrhea found that a single dose of ertapenem was 99% effective, on par with ceftriaxone, which is recommended as first-line treatment.
Henry JC deVries, MARYLANDdermatologist and professor of skin infections in the department of infectious diseases at the Amsterdam Public Health Service, said he initiated the study in response to reports of strains of gonorrhea being resistant or showing reduced susceptibility to ceftriaxone.
Henri JC de Vries
“The WHO has urged action to prevent gonorrhea from becoming an incurable disease,” de Vries told Healio. “Several new antibiotics have been developed showing in vitro or in vivo efficacy against gonorrhea but are years away from registration. However, existing registered drugs with absent or low usage for gonorrhea might be effective.
De Vries and colleagues evaluated the efficacy of ertapenem, gentamicin, and fosfomycin in a randomized, controlled, double-blind, non-inferiority trial at the Sexual Health Center Amsterdam. The study included the three experimental groups and a control group that received ceftriaxone, all of which were adults aged 18 or older with anorectal or urogenital gonorrhea.
They assigned participants in a 1:1:1:1 ratio to receive ceftriaxone 500 mg intramuscularly which has been self-recommended for gonorrhea since 2020 ertapenem 1000 mg intramuscularly, 5 mg/ kg gentamicin intramuscularly or 6 g fosfomycin orally. The primary outcome was the proportion of participants with a predefined negative primary infected site nucleic acid amplification test between 7 and 14 days after treatment.
Between September 18, 2017 and June 5, 2020, they assigned 346 (16%) participants to receive either ceftriaxone (n=103), ertapenem (n=103), gentamicin (n=102) or fosfomycin (n = 38). They stopped the fosfomycin arm early after an interim analysis showed less than 60% efficacy.
In the primary per-protocol analysis, 100% of patients in the ceftriaxone group, 99% of patients in the ertapenem group, 93% of patients in the gentamicin group, and 12% of patients in the fosfomycin group were eliminated. NOTeisseria gonorrhea (0.01 for ertapenem and 0.07 for gentamicin), demonstrating that ertapenem was non-inferior to ceftriaxone. In a modified intention-to-treat analysis, the risk differences with ceftriaxone were 0.08 for ertapenem and 0.11 for gentamicin.
“Gonorrhea treatment options are dwindling, so there is an urgent need for new treatment options. Still, it could be years before these new treatment options become available,” de Vries said. “In the meantime, antibiotics already registered are potential options worth exploring.”