Multicenter trial of single-dose azithromycin vs. ceftriaxone in the treatment of uncomplicated gonorrhea. Azithromycin Gonorrhea Study Group.
OBJECTIVE
Azithromycin is a new, long-acting azalide antibiotic that is active against Neisseria gonorrhoeae. A single oral dose of 1.0 g is effective against uncomplicated genital infection with Chlamydia trachomatis.


OBJECTIVE
To compare the efficacy and tolerance of single-dose treatment of uncomplicated gonorrhea with azithromycin, 2.0 g orally, and ceftriaxone, 250 mg intramuscularly.


METHODS
Seven hundred twenty-four men and women with presumptive, uncomplicated gonorrhea were treated with azithromycin 2.0 g orally or ceftriaxone 250 mg intramuscularly in a 2:1 ratio in a multicenter, open, randomized control trial in 10 public sexually transmitted disease clinics in the United States. Patients were followed up in 5 to 9 days and, for a subset of patients, 12 to 18 days after treatment. The main outcome measures were the isolation of N. gonorrhoeae and C. trachomatis and patient-reported side effects.


RESULTS
Among infected patients who returned for follow-up, N. gonorrhoeae was eradicated from all anatomic sites in 370 of 374 (98.9%; 95% confidence interval [95%CI] 97.9%-100%) treated with azithromycin and 171 of 175 (97.7%; 95%CI 95.5%-99.9%) given ceftriaxone. Treatment with either drug was effective in all 73 patients infected with beta-lactamase-producing N. gonorrhoeae. Chlamydial infection was eradicated in all 17 patients given azithromycin who returned and were recultured at follow-up and in two of seven patients given ceftriaxone (P < 0.001). Gastrointestinal side effects occurred in 35.3% (95%CI 30.7%-39.8%) of patients given azithromycin; of those with symptoms, these were moderate in 10.1% and severe in 2.9%.


CONCLUSIONS
Azithromycin 2.0 g and ceftriaxone 250 mg are equally effective in the treatment of uncomplicated gonorrhea. Azithromycin was associated with a relatively high frequency of gastrointestinal side effects and is expensive, but it has the advantages of oral administration and efficacy against concomitant chlamydial infection.
Handsfield
H H
HH
University of Washington, Seattle, USA.
Dalu
Z A
ZA
Martin
D H
DH
Douglas
J M
JM
McCarty
J M
JM
Schlossberg
D
D
D000284:Administration, Oral; D000328:Adult; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D017963:Azithromycin / Q000627:therapeutic use*; D002443:Ceftriaxone / Q000627:therapeutic use*; D002511:Cephalosporins / Q000627:therapeutic use*; D005260:Female; D006069:Gonorrhea / Q000188:drug therapy* / Q000382:microbiology; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008826:Microbial Sensitivity Tests; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D002511:Cephalosporins; D002443:Ceftriaxone; D017963:Azithromycin