The efficacy and safety of gentamicin plus azithromycin and gemifloxacin plus azithromycin as treatment of uncomplicated gonorrhea

Clin Infect Dis. 2014 Oct 15;59(8):1083-91. doi: 10.1093/cid/ciu521. Epub 2014 Jul 16.


Background: Ceftriaxone is the foundation of currently recommended gonorrhea treatment. There is an urgent need for backup treatment options for patients with cephalosporin allergy or infections due to suspected cephalosporin-resistant Neisseria gonorrhoeae. We evaluated the efficacy and tolerability of 2 combinations of existing noncephalosporin antimicrobials for treatment of patients with urogenital gonorrhea.

Methods: We conducted a randomized, multisite, open-label, noncomparative trial in 5 outpatient sexually transmitted disease clinic sites in Alabama, California, Maryland, and Pennsylvania. Patients aged 15-60 years diagnosed with uncomplicated urogenital gonorrhea were randomly assigned to either gentamicin 240 mg intramuscularly plus azithromycin 2 g orally, or gemifloxacin 320 mg orally plus azithromycin 2 g orally. The primary outcome was microbiological cure of urogenital infections (negative follow-up culture) at 10-17 days after treatment among 401 participants in the per protocol population.

Results: Microbiological cure was achieved by 100% (lower 1-sided exact 95% confidence interval [CI] bound, 98.5%) of 202 evaluable participants receiving gentamicin/azithromycin, and 99.5% (lower 1-sided exact 95% CI bound, 97.6%) of 199 evaluable participants receiving gemifloxacin/azithromycin. Gentamicin/azithromycin cured 10 of 10 pharyngeal infections and 1 of 1 rectal infection; gemifloxacin/azithromycin cured 15 of 15 pharyngeal and 5 of 5 rectal infections. Gastrointestinal adverse events were common in both arms.

Conclusions: Gentamicin/azithromycin and gemifloxacin/azithromycin were highly effective for treatment of urogenital gonorrhea. Gastrointestinal adverse events may limit routine use. These non-cephalosporin-based regimens may be useful alternative options for patients who cannot be treated with cephalosporin antimicrobials. Additional treatment options for gonorrhea are needed. Clinical Trials Registration. NCT00926796.

Keywords: Neisseria gonorrhoeae; azithromycin; gemifloxacin; gentamicin; gonorrhea treatment.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Administration, Oral
  • Adolescent
  • Adult
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use*
  • Azithromycin / adverse effects
  • Azithromycin / therapeutic use*
  • Drug Therapy, Combination / adverse effects
  • Drug Therapy, Combination / methods
  • Drug-Related Side Effects and Adverse Reactions / epidemiology
  • Drug-Related Side Effects and Adverse Reactions / pathology
  • Female
  • Fluoroquinolones / adverse effects
  • Fluoroquinolones / therapeutic use*
  • Gastrointestinal Diseases / chemically induced
  • Gastrointestinal Diseases / epidemiology
  • Gastrointestinal Diseases / pathology
  • Gemifloxacin
  • Gentamicins / adverse effects
  • Gentamicins / therapeutic use*
  • Gonorrhea / drug therapy*
  • Humans
  • Injections, Intramuscular
  • Male
  • Middle Aged
  • Naphthyridines / adverse effects
  • Naphthyridines / therapeutic use*
  • Neisseria gonorrhoeae / isolation & purification
  • Treatment Outcome
  • United States
  • Young Adult


  • Anti-Bacterial Agents
  • Fluoroquinolones
  • Gentamicins
  • Naphthyridines
  • Azithromycin
  • Gemifloxacin

Associated data