Aims: Efficacy and safety of a short-duration treatment of azithromycin 1.5% eye drops versus oral azithromycin to treat active trachoma.
Methods: Randomised, controlled, double-masked, double-dummy, non-inferiority explanatory study including 670 children from Guinea Conakry and Pakistan if: 1–10 years old; active trachoma (TF+TI0 or TF+TI+ on simplified World Health Organisation (WHO) scale). Three groups received either: azithromycin 1.5% eye drops twice daily for 2 days, for 3 days or azithromycin single 20 mg/kg oral dose. Patients’ contacts were treated whenever possible. Clinical evaluation was performed using a binocular loupe. Primary efficacy variable was the cure (no active trachoma (TF0)) at day 60. Non-inferiority margin for difference between cure rates was 10%.
Results: Cure rate in per protocol set was as follows: 93.0%, 96.3% and 96.6% in 2-day group 3-day group, and oral treatment group, respectively. Azithromycin 1.5% groups were non-inferior to oral azithromycin. The intend to treat (ITT) analysis supported the results. Clinical re-emergence rate was low: 4.2%. Ocular tolerance was similar for all groups. No treatment related adverse events were reported. Logistic regression analyses found prognostic factors such as: country (p<0.001) and trachoma severity (p = 0.003).
Conclusions: In active trachoma, azithromycin eye drops twice daily for 2 or 3 days are as efficient as the WHO’s reference treatment and represent an innovative alternative to oral azithromycin.
- GCP, good clinical practice
- ITT, intend to treat
- TF0, no active trachoma
- (TF+TI0), trachomatous inflammation − follicular
- (TF+TI), trachomatous inflammation − follicular and intense
- WHO, World Health Organisation
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Published Online First 27 September 2006
Funding: This clinical trial was sponsored by Laboratoires Théa, Clermont-Ferrand, France.
Competing interests: IC, PG, AG, TA, TB and PYR have no financial interest in Laboratoires Théa and the product Azyter. PP and LD are employees of Laboratoires Théa.
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