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Randomized Trial in Ethiopia

Sheila K. West, PhD; Emily S. West, PhD; Wondu Alemayehu, MD, MPH; Muluken Melese, MD, MPH; Beatriz Munoz, MS; Alemush Imeru, MPH; Alemayehu Worku, MD; Charlotte Gaydos, DrPH, MS, MPH; Curtis L. Meinert, PhD; Thomas Quinn, MD

Arch Ophthalmol. 2006;124:309-314.

Background  Trichiasis recurrence following surgery is a serious problem for trachoma programs.

Objective  To determine if postoperative treatment with azithromycin compared with topical tetracycline reduces recurrence up to 1 year, and if azithromycin treatment of household members provides additional benefit compared with treating only the surgical patient.

Design  A randomized, single-masked, clinical trial was conducted in Ethiopia. A total of 1452 patients with trichiasis were randomized 1:1:1 to the following 3 arms: single-dose (1 g) oral azithromycin alone, single-dose azithromycin for household members (20 mg/kg up to 1 g) plus the patient, or topical tetracycline (twice per day for 6 weeks).

Main Outcome Measures  Trichiasis recurrence within 1 year following surgery.

Results  The combined azithromycin groups had significantly fewer recurrences, 6.9 of 100 person-years overall, compared with topical tetracycline, 10.3 of 100 person-years (P = .047). There was no additional reduction in the arm that also treated household members, 8.1 of 100 person-years, compared with treating the surgical patients alone, 5.8 of 100 person-years (P = .19).

Conclusions  In trachoma-endemic areas, a single dose of azithromycin reduced postoperative trichiasis recurrence rates by one third compared with topical tetracycline.

Application to Clinical Practice  In countries where azithromycin is part of the Trachoma Control Program, patients with trachomatous trichiasis should be treated postoperatively to prevent recurrence.

Author Affiliations: Dana Center for Preventive Ophthalmology, Wilmer Eye Institute (Drs S. West and E. West, Ms Munoz and Ms Imeru) and Department of Infectious Diseases (Drs Gaydos and Quinn), Johns Hopkins University, Baltimore, Md; ORBIS International, Addis Ababa, Ethiopia (Drs Alemayehu, Melese, and Worku); Center for Clinical Trials, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md (Dr Meinert).

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