Ertapenem noninferior to ceftriaxone in treating gonorrhea, study finds
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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 therapy.
Henry J.C. de Vries, MD, a dermatologist and professor of skin infections in the department of infectious diseases at the Public Health Service Amsterdam, said they initiated the study in response to reports of gonorrhea strains that are resistant or have decreased susceptibility to ceftriaxone.
“WHO has urged action to prevent gonorrhea from becoming an untreatable 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 to sparse use against gonorrhea might be efficacious.”
De Vries and colleagues evaluated the efficacy of ertapenem, gentamicin and fosfomycin in a randomized, controlled, double-blind, noninferiority trial at the Centre for Sexual Health in Amsterdam. The study consisted of the three experimental groups and a control group that received ceftriaxone, all composed of adults aged 18 years or older with anorectal or urogenital gonorrhea.
They assigned participants in a 1:1:1:1 ratio to receive intramuscular 500 mg ceftriaxone which has been recommended by itself for gonorrhea since 2020 intramuscular 1,000 mg ertapenem, intramuscular 5 mg/kg gentamicin or oral 6 g fosfomycin. The primary outcome was the proportion of participants with a negative nucleic acid amplification test of the predefined primary infected site between 7 and 14 days after treatment.
Between Sept. 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 halted the fosfomycin arm early after an interim analysis revealed 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 cleared Neisseria gonorrhoeae (0.01 for ertapenem and 0.07 for gentamicin), demonstrating that ertapenem was noninferior to ceftriaxone. In a modified intention-to-treat analysis, risk differences compared with ceftriaxone were 0.08 for ertapenem and 0.11 for gentamicin.
“Treatment options for gonorrhea are diminishing, so there is an urgent need for new treatment options. Yet, it might take years before these new treatment options are available,” de Vries said. “In the meantime, already registered antibiotics are potential options worth exploring.”
Perspective
Back to TopJeffrey D. Klausner, MD, MPH
This study included nearly 100 participants with gonococcal infections of the urogenital tract or rectum treated with ertapenem. The investigators found that the success rate was 99%. That is highly efficacious and very encouraging. Ertapenem has been used to treat drug-resistant gonococcal infections in the past. Given the long-standing efficacy, safety profile and low cost of the recommended treatment of ceftriaxone 500 mg by injection, however, I do not think we are ready to replace ceftriaxone in the treatment of gonorrhea, but ertapenem is certainly a promising alternative for urogenital or rectal infections. Remember, CDC guidelines recommend treatment of all recent sex partners in the past 60 days of someone being diagnosed with gonorrhea.
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