title: Single-dose therapy of gonococcal ophthalmia neonatorum with ceftriaxone.
abstract: 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.
mesh_terms: D002443:Ceftriaxone / Q000008:administration & dosage* / Q000494:pharmacology; D002986:Clinical Trials as Topic; D004352:Drug Resistance, Microbial; D005500:Follow-Up Studies; D005839:Gentamicins / Q000008:administration & dosage; D006801:Humans; D007231:Infant, Newborn; D007273:Injections, Intramuscular; D007612:Kanamycin / Q000008:administration & dosage; D009344:Neisseria gonorrhoeae / Q000187:drug effects / Q000302:isolation & purification; D009878:Ophthalmia Neonatorum / Q000188:drug therapy* / Q000382:microbiology; D011897:Random Allocation; D013752:Tetracycline / Q000008:administration & dosage
chemical_list: D005839:Gentamicins; D007612:Kanamycin; D002443:Ceftriaxone; D013752:Tetracycline