Single-dose therapy of gonococcal ophthalmia neonatorum with ceftriaxone

N Engl J Med. 1986 Nov 27;315(22):1382-5. doi: 10.1056/NEJM198611273152203.


We conducted a randomized clinical trial comparing a single intramuscular dose of 125 mg of ceftriaxone with a single intramuscular dose of 75 mg of kanamycin followed by topical gentamicin for seven days, and with a single intramuscular dose of 75 mg of kanamycin followed by topical tetracycline for seven days, in the treatment of gonococcal ophthalmia neonatorum in Nairobi, Kenya. Of 122 newborns with culture-proved gonococcal ophthalmia neonatorum, 105 returned for follow-up. Sixty-one infants (54 percent) received ceftriaxone, 32 received kanamycin plus topical gentamicin, and 29 received kanamycin plus topical tetracycline. Sixty-six (54 percent) of the Neisseria gonorrhoeae isolates were penicillinase producing. All 55 newborns who received ceftriaxone and returned for follow-up were clinically and microbiologically cured. One of 26 returning newborns who received kanamycin plus tetracycline and 2 of 24 returning newborns who received kanamycin plus gentamicin had persistent or recurrent gonococcal conjunctivitis. Ceftriaxone also eradicated oropharyngeal gonococcal infection in 18 newborns, whereas oropharyngeal infection persisted in 2 of 8 newborns who had received kanamycin (P not significant). We conclude that 125 mg of ceftriaxone as a single intramuscular dose is very effective therapy for gonococcal ophthalmia neonatorum, with marked efficacy against extraocular infection and without the need for concomitant topical antimicrobial therapy.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Ceftriaxone / administration & dosage*
  • Ceftriaxone / pharmacology
  • Clinical Trials as Topic
  • Drug Resistance, Microbial
  • Follow-Up Studies
  • Gentamicins / administration & dosage
  • Humans
  • Infant, Newborn
  • Injections, Intramuscular
  • Kanamycin / administration & dosage
  • Neisseria gonorrhoeae / drug effects
  • Neisseria gonorrhoeae / isolation & purification
  • Ophthalmia Neonatorum / drug therapy*
  • Ophthalmia Neonatorum / microbiology
  • Random Allocation
  • Tetracycline / administration & dosage


  • Gentamicins
  • Kanamycin
  • Ceftriaxone
  • Tetracycline