Single Oral Dose of Azithromycin Versus 5 Days of Oral Erythromycin or No Antibiotic in Treatment of Campylobacter Enterocolitis in Children: A Prospective Randomized Assessor‐Blind Study

Abstract

To evaluate efficacy of a single oral azithromycin dose versus standard oral erythromycin regimen or no antibiotic for Campylobacter enterocolitis in children younger than or equal to 12 years of age. Randomized parallel group assessor-blind trial testing for inequality in efficacy between treatments was done. Patients (N = 120) were enrolled at less than or equal to 48 hours since disease onset to receive erythromycin 50 mg kg day for 5 days, single-dose azithromycin 20 mg/kg or 30 mg/kg, or no antibiotic (no treatment control) (1: 1: 1: 1). Antibiotics were commenced 8 to 10 hours after enrollment. Patients were assessed at 24-hour intervals for 6 days. In the intent-to-treat analysis, Campylobacter eradication was achieved in 20 of 30 controls and in all of the patients treated with antibiotic. Incidence of clinical cure during the observed period was 15 of 30 in the control, 14 of 30 in the erythromycin, 20 of 30 in the lower, and 25 of 30 in the higher azithromycin dose group. With adjustment for age, sex, baseline disease severity, and disease duration before enrollment, only azithromycin 30 mg/kg was superior to no treatment: incidence ratio (IR) 1.76 (95% confidence interval [CI] 1.11-2.87). It was also superior to erythromycin (IR 1.80, 97.5% CI 1.13-2.84). Regarding time to clinical cure, only azithromycin 30 mg/kg was superior to no treatment (adjusted hazard ratio [HR] 4.90, 95% CI 2.44-9.84). It was also superior to erythromycin (HR 4.17, 97.5% CI 1.91-9.09). All treatments were well tolerated. The administration of single oral dose of azithromycin 30 mg/kg early after disease onset effectively eradicates the pathogen and accelerates clinical cure in childhood Campylobacter enterocolitis. It is clinically superior to an early commenced 5-day erythromycin regimen, which apparently conveys no clinically relevant benefit over no antibiotic treatment.