title: The efficacy and safety of gentamicin plus azithromycin and gemifloxacin plus azithromycin as treatment of uncomplicated gonorrhea.
abstract: 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.
authors.affiliation: Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Robert D
authors.initials: RD
authors.lastname: Kirkcaldy
authors.affiliation: Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Hillard S
authors.initials: HS
authors.lastname: Weinstock
authors.affiliation: Department of Biostatistics, University of Arkansas Medical Sciences, Little Rock.
authors.forename: Page C
authors.initials: PC
authors.lastname: Moore
authors.affiliation: San Francisco Department of Public Health, California.
authors.forename: Susan S
authors.initials: SS
authors.lastname: Philip
authors.affiliation: University of Pittsburgh and Allegheny County Health Department, Pennsylvania.
authors.forename: Harold C
authors.initials: HC
authors.lastname: Wiesenfeld
authors.affiliation: Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: John R
authors.initials: JR
authors.lastname: Papp
authors.affiliation: County of Los Angeles, Department of Public Health, California.
authors.forename: Peter R
authors.initials: PR
authors.lastname: Kerndt
authors.affiliation: FHI360, Durham, North Carolina.
authors.forename: Shacondra
authors.initials: S
authors.lastname: Johnson
authors.affiliation: Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Khalil G
authors.initials: KG
authors.lastname: Ghanem
authors.affiliation: University of Alabama at Birmingham Jefferson County Department of Health, Birmingham, Alabama.
authors.forename: Edward W
authors.initials: EW
authors.lastname: Hook
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D017963:Azithromycin / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D024841:Fluoroquinolones / Q000009:adverse effects / Q000627:therapeutic use*; D005767:Gastrointestinal Diseases / Q000139:chemically induced / Q000453:epidemiology / Q000473:pathology; D000077735:Gemifloxacin; D005839:Gentamicins / Q000009:adverse effects / Q000627:therapeutic use*; D006069:Gonorrhea / Q000188:drug therapy*; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D009287:Naphthyridines / Q000009:adverse effects / Q000627:therapeutic use*; D009344:Neisseria gonorrhoeae / Q000302:isolation & purification; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D024841:Fluoroquinolones; D005839:Gentamicins; D009287:Naphthyridines; D017963:Azithromycin; D000077735:Gemifloxacin
keywords: Neisseria gonorrhoeae; azithromycin; gemifloxacin; gentamicin; gonorrhea treatment