EPIC-15 Evaluating Pediatric Ivermectin (CHILD-IVITAB) in Children Under 15 kilograms

BACKGROUND: The safety, tolerability, pharmacokinetics, and efficacy of standard ivermectin is currently being evaluated in scabies infected children <15 kg. We are currently lacking an appropriate child-friendly pediatric formulation for children <15kg which can be readily used in the clinic and mass drug administration settings. GAP: A novel oro-dispersible minitablet formulation of ivermectin (CHILD-IVITAB) which can completely dissolve in less than 10 seconds has been developed. This novel CHILD-IVITAB formulation can be used for scabies and numerous other neglected tropical diseases in children <15 kg. HYPOTHESIS: The novel CHILD-IVITAB formulation will be safe, tolerable, acceptable, possess a suitable pharmacokinetic profile and be efficacious against scabies in children <15 kg. METHODS: A phase IIB clinical trial with CHILD-IVITAB (200 and 400 µg/kg) will be conducted in scabies infected children <15 kg in Brazil. Safety, tolerability, and efficacy will be assessed in a similar manner as the ongoing Ivermectin Safety in Small Children trial, pharmacokinetics will be assessed by LC-MS, and acceptability measured by the ClinSearch Acceptability Score Test. RESULTS: “Pending”. IMPACT: This novel, oro-dispersible ivermectin minitablet has the potential to be used in clinic and mass drug administration settings to treat scabies and numerous neglected tropical diseases in children <15 kg a safe and efficacious manner.