Treatment of giardiasis in children: Randomized trial of rectal metronidazole versus oral tinidazole

Abstract

Abstract Objectives We investigated the efficacy, safety and acceptance of rectally administered metronidazole for the treatment of giardiasis in children. Patients and Methods This study (ClinicalTrials.gov Identifier: NCT02942485) was an open-labeled randomized comparison of a 3-day-course of rectal metronidazole and single-dose oral tinidazole in children with giardiasis. Clinical cure was defined as the resolution of symptoms by day 10 post-treatment. Microbiological eradication was assessed with stool enzyme immunoassay for G.duodenalis antigen on day 7-10 post-treatment. Results The study was terminated due to the extremely slow enrollment. We describe the outcome for six patients treated with rectal metronidazole and one patient treated with oral tinidazole. All symptomatic patients (4/4) were clinically cured with rectal metronidazole. Microbiological eradication was successful after the first treatment course in all tested patients (6/6), of whom five were treated with rectal metronidazole and one with oral tinidazole. Side effects were reported in one patient and were restricted to a single episode of loose stool after the third dose of rectal metronidazole. The majority of caregivers (4/6) considered the administration of rectal metronidazole relatively easy. Conclusions We provide a proof of principle for the efficacy of rectally administered metronidazole in the treatment of giardiasis.