Open study of the safety and efficacy of a single oral dose of azithromycin for the treatment of uncomplicated gonorrhoea in men and women

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Abstract
An open, non-comparative study was undertaken to assess the safety and efficacy of a single 1 g oral dose of azithromycin in patients with uncomplicated gonorrhoea. One hundred and eighteen patients (105 male, 13 female) took part in the study. Only patients culture-positive for Neisseria gonorrhoeae were evaluated. The majority of male patients (84) had urethra] gonorrhoea, but four had rectal and two pharyngeal infections. Four patients had positive cultures at more than one site (two urethral and rectal; two urethral and pharyngeal). All nine female patients had infection of the cervix only. Bacteriological eradication of N. gonorrhoeae was achieved in 76/82 (93%) patients with positive urethral cultures, 9/9 with positive cervical, 4/4 with positive rectal, and 2/2 with positive pharyngeal cultures. Twenty-two patients (18 males, four females) had concomitant chlamydial infection. Chlamydia trachomatis was eradicated in all patients who returned for follow-up assessment and in whom culture was done. Azithromycin was very well tolerated, with only two patients reporting mild-to-moderate side-effects. This study shows that single-dose azithromycin is effective in uncomplicated gonorrhoea and in mixed gonococcal and chlamydial infections.

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