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Randomized trial of high dose azithromycin compared to standard dosing for children with severe trachoma in Tanzania
J Peter Campbell1, Harran Mkocha, Beatriz Munoz
1Dana Center for Preventive Ophthalmology, Wilmer Eye Institute, Johns Hopkins University, 600 N Wolfe St., Baltimore, MD 21205, USA.
Insights
A higher dose of azithromycin (30 mg/kg) did not significantly improve Chlamydia trachomatis infection clearance in children with severe trachoma compared to the standard dose (20 mg/kg) six weeks post-treatment.
Area of Science:
- Ophthalmology
- Infectious Diseases
- Pediatrics
Background:
- * *Chlamydia trachomatis* (C. trachomatis) infection can persist in children despite a single 20 mg/kg dose of azithromycin.
- * Severe trachoma necessitates effective treatment strategies to prevent ongoing infection and disease progression.
Purpose of the Study:
- * To compare the efficacy of a 30 mg/kg single dose of azithromycin versus a 20 mg/kg single dose in clearing *C. trachomatis* infection in children with severe trachoma.
- * To evaluate *C. trachomatis* infection rates at six weeks post-treatment in two different azithromycin dosage groups.
Main Methods:
- * Ninety-nine children with severe trachoma were enrolled and randomized to receive either 20 mg/kg or 30 mg/kg of azithromycin.
- * Baseline and six-week follow-up assessments included clinical evaluation for trachoma and laboratory testing (PCR) for *C. trachomatis* infection.
- * Dosing was weight-based and observed, with laboratory personnel masked to treatment assignments.
Main Results:
- * Both azithromycin dosage groups showed significant reductions in *C. trachomatis* infection and severe trachoma from baseline to six weeks.
- * At six weeks, 12% of the 20 mg/kg group and 15% of the 30 mg/kg group remained PCR positive for *C. trachomatis*.
- * There was no statistically significant difference in *C. trachomatis* infection rates between the two treatment groups at six weeks (p = 0.71).
Conclusions:
- * Increasing the single dose of azithromycin to 30 mg/kg did not lead to a significantly greater reduction in *C. trachomatis* infection rates at six weeks post-treatment in children with severe trachoma.
- * The standard 20 mg/kg single dose of azithromycin appears to be as effective as the higher 30 mg/kg dose for *C. trachomatis* infection in this pediatric population.
Background:
Children with a heavy load of C. trachomatis infection may continue to be infected following a single dose of 20 mg/kg of azithromycin. We compared the C. trachomatis infection rates at six weeks post-treatment of children randomized to 30 mg/kg single dose of azithromycin versus 20 mg/kg single dose of azithromycin.
Methods:
Ninety-nine children with severe trachoma (defined as either trachoma intense or follicular trachoma with ten or more follicles) were enrolled and randomly assigned. Baseline data on age, sex, and trachoma status was obtained, and swabs for determination of C. trachomatis were taken. Dosing was weight-based and observed. Children were followed up at six weeks for trachoma and infection. The laboratory was masked to treatment assignment.
Results:
Both groups experienced reductions in infection and in severe trachoma. Twelve percent of the 20 mg/kg group were PCR positive at 6 weeks, compared with 69% at baseline, an 82% reduction (p-value < .001). In the 30 mg/kg group, 15% were infected, compared with 62% at baseline, a 76% reduction (p < .001). The rate of infection comparing treatment groups was not significantly different at 6 weeks (p = 0.71). Analyses on children who were infected at baseline showed those remaining positive at six weeks were 18%, and 14% in the standard and high dose groups, respectively.
Conclusion:
Increasing the single dose of azithromycin to 30 mg/kg in children with severe trachoma did not result in significantly less infection at six weeks post-treatment compared to 20 mg/kg.
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