Two open, randomized, single centre studies have investigated the efficacy and safety of azithromycin (CP-62,993) in the treatment of infections by azithromycin-sensitive pathogens: (A) acute bacterial infections of skin or soft tissue (compared with erythromycin; n = 82); and (B) urethritis and/or cervicitis caused by Neisseria gonorrhoeae and/or Chlamydia trachomatis (compared with doxycycline; n = 108). In study A, azithromycin was administered to 42 patients for five days at a dosage of 250 mg bd on day 1 and 250 mg once daily on days 2–5; erythromycin was given to 40 patients for seven days at a dosage of 500 mg every 6 h. In study B, azithromycin was administered either as a single 1 g dose or as a single 500 mg dose on day 1 and 250 mg once daily on days 2 and 3; doxycycline was given at a dose of 100 mg every 12 h for seven days. In study A, 68 patients were clinically assessed: clinical cure or improvement in patients receiving azithromycin or erythromycin was achieved in 86% and 82%, respectively. The principal causative pathogen was Staphylococcus aureus ; there was eradication of 15/25 pathogens (60%) with azithromycin and 13/23 (57%) with erythromycin. In study B, 94 and 93 patients were clinically assessed at weeks 1 and 2, respectively: clinical cure was achieved with all treatment regimens at week 1; at week 2 there was reappearance of symptoms in one patient with a mixed infection who had received 3-day azithromycin. Bacteriological eradication was achieved with 1-day and 3-day azithromycin in all patients at weeks 1 and 2; with doxycycline, eradication was achieved in all patients with gonococcal and mixed infections, and in 13/14 patients with chlamydial infection. Side effects (gastrointestinal) occurred in five patients (12.5%) receiving erythromycin, but in none of those on azithromycin or doxycycline. No clinically significant laboratory abnormalities were attributed to any study treatment. These studies suggest that azithromycin is as effective as erythromycin in the treatment of skin and soft-tissue infections, and that in sexually transmitted gonococcal and chlamydial infections single-dose azithromycin is as effective as 7-day doxycycline therapy. The successful single-dose treatment of genitourinary chlamydial infections may make azithromycin a significant advance in the treatment of this condition.
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A Lassus (1990) studied this question.