Safety of Single-Dose Oral Cefixime, Intramuscular Ceftriaxone, or Intramuscular Gentamicin for the Treatment of Gonorrhea: A Systematic Review and Meta-analysis

Objective: To compare the incidence and types of adverse effects between 3 recommended treatment options for gonorrhea and to compare the incidence of injection site pain between single-dose intramuscular ceftriaxone and gentamicin. Data Sources: A keyword search of MEDLINE (1966 to September 2020), EMBASE (1947 to September 2020), and International Pharmaceutical Abstracts (1970 to September 2020) was conducted. The electronic search was supplemented with manual screening of references. Study Selection and Data Extraction: Comparator studies reporting adverse effect outcomes of treatment with cefixime, ceftriaxone, or gentamicin for gonorrhea in humans were included. Data extracted included study year, authors, aim, setting, population, dosing protocols, and outcome results. Data Synthesis: A total of 298 articles were identified, of which 6 met inclusion criteria. Two randomized controlled trials compared ceftriaxone and gentamicin. Four randomized controlled trials compared cefixime and ceftriaxone. No differences were noted for the occurrence of at least 1 adverse effect between gentamicin and ceftriaxone (odds ratio [OR] = 0.81; 95% CI = 0.56-1.18) or between cefixime and ceftriaxone (OR = 1.11; 95% CI = 0.21-5.93). Injection site pain (ceftriaxone and gentamicin) and other adverse effects (all drugs) were common but occurred at similar rates between groups. Relevance to Patient Care and Clinical Practice: Results of this review show a lack of signal for safety concerns with gentamicin-based regimens for the treatment of gonorrhea. Future research should investigate patient acceptability, especially for intramuscular injections. Conclusions: The use of single-dose cefixime, ceftriaxone, and gentamicin-based regimens for treatment of gonorrhea appears to be safe and acceptable for use in practice.

Automated summary

This study compared the incidence and types of adverse effects between 3 recommended treatment options for gonorrhea and the incidence of injection site pain between single-dose intramuscular ceftriaxone and gentamicin. The results showed that there were no significant differences in adverse effects between the treatment options and injection site pain was common but similar between groups. The use of single-dose cefixime, ceftriaxone, and gentamicin-based regimens for gonorrhea appears to be safe and acceptable for practice.