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Gentamicin should generally not be considered a first-line option in the treatment of gonorrhea, however it may be useful in certain patients, according to the results of a recent non-inferiority trial.
The multicenter, parallel-group, pragmatic trial aimed to evaluate gentamicin as a therapeutic alternative to ceftriaxone for the treatment of gonorrhea. Patients included in the study were 16 to 70 years old and had a diagnosis of uncomplicated genital, pharyngeal, or rectal gonorrhea. They were randomly assigned (1:1) to receive one intramuscular injection of gentamicin 240mg or ceftriaxone 500mg in addition to one 1g dose of oral azithromycin.
“The primary outcome was clearance of Neisseria gonorrhoeae at all initially infected sites, defined as a negative nucleic acid amplification test 2 weeks post treatment,” the study authors explained. The primary endpoint analysis only included patients with follow-up data, regardless of their baseline visit test result. “The margin used to establish non-inferiority was a lower confidence limit of 5% for the risk difference,” the study authors added.
A total of 720 patients were enrolled in the study. Of the 358 patients randomly assigned to the gentamicin group, 292 (82%) had available primary outcome data while 306 of the 362 (85%) patients assigned to receive ceftriaxone had available data. The study authors reported that infection had cleared in 98% of patients in the ceftriaxone group (299/306) versus 91% of patients in the gentamicin group (267/292) 2 weeks after treatment (adjusted risk difference: –6.4%; 95% CI: –10.4%, –2.4%).
Findings of the study also revealed that 98% of ceftriaxone patients (151/154) with a genital infection had clearance at follow-up compared with 94% of gentamicin patients (163/174) (adjusted risk difference: –4.4%; 95% CI: –8.7, 0). Additionally, it was found that 96% of ceftriaxone patients (N=108) with a pharyngeal infection had clearance at follow-up vs 80% of gentamicin patients (N=82) (adjusted risk difference: –15.3%; 95% CI: –24.0, –6.5). Moreover, 98% of ceftriaxone patients (N=134) had a cleared rectal infection at follow-up compared with 90% of gentamicin patients (N=107) (adjusted risk difference: –7.8%; 95% CI:–13.6, –2.0).
“In conclusion, we found that gentamicin plus azithromycin cannot be considered non-inferior to ceftriaxone plus azithromycin, with a relatively higher frequency of treatment failure occurring in patients with extragenital gonorrhea who were treated with gentamicin,” the study authors stated. “However, gentamicin combined with 1g azithromycin achieved a cure rate of 94% for genital gonorrhea and its use might be appropriate in patients who are allergic, intolerant, or harbour a ceftriaxone-resistant infection.”
For more information visit thelancet.com.
