The Committee reviewed two applications for the addition of azithromycin to the Model List. One application was submitted by Médecins sans Frontières (MSF), Brussels, Belgium, for inclusion as an individual core list medicine for the treatment of chlamydial infection and trachoma; the second application was made by the Department of Reproductive Health and Research, WHO, for inclusion as an individual core list medicine for the treatment of genital chlamydia. The MSF application was reviewed and supported by the Department of Reproductive Health and Research, WHO.

The Committee noted that azithromycin, a macrolide antibiotic, has antimicrobial activity against a wide variety of microbes. Its effectiveness against Chlamydia trachomatis genital infection with a single dose has been demonstrated in studies cited in the applications. Cited studies also show that azithromycin is safe for use in both growing adolescents and in pregnancy, both contraindications for tetracycline, the main alternative. The Committee acknowledged that the safety of this medicine in these sectors of the population, combined with the advantages offered by a single-dose curative regimen, support the selection of azithromycin for the treatment of this particular disease.

The MSF application also cited studies that indicate that oral azithromycin is as effective in treating trachoma as antibiotic ointments. The Committee recognized the advantage of a single oral dose treatment of an infection, especially when it is directly observed, over a prolonged course of prescribed medication.

The Committee thus recommended that azithromycin (as capsules, 250mg, 500mg and as a oral suspension, 200mg/5ml) be added to the Model List as a core list medicine (in section 6.2.2), for the single dose treatment of genital C. trachomatis infection and of trachoma only. This recommendation was made in view of the effectiveness and safety of azithromycin as documented in the applications, and because of its ease of use relative to the principal alternatives (i.e. doxycycline twice daily for a week, or tetracycline ophthalmic ointment for 6 weeks). The Committee recommended that the entry be annotated with the following footnote:

Only listed for single dose treatment of genital C. trachomatis and of trachoma.