The EPIC-15 trial will evaluate the safety, pharmacokinetics, acceptability, and efficacy of pediatric ivermectin (CHILD-IVITAB) in scabies infected children weighing 5 to less than 15 kg. This trial will support future efforts to expand the indication of ivermectin treatment to infants weighing 5 to less than 15 kg to treat numerous NTDs, allowing this young age group equitable access to the numerous benefits of pediatric ivermectin therapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Ivermectin (200 µg/kg) oro-dispersible minitablets
Ivermectin (400 µg/kg) oro-dispersible minitablets
Fundação de Dermatologia Tropical e Venereologia Alfredo da Matta (FUAM)
Manaus, Brazil
Population pharmacokinetic properties of ivermectin concentrations at escalating doses in children <15 kg
Time frame: Days 0, 3, 7, 10, 14
Safety of oral ivermectin measures by pruritus outcomes assessed by a composite score recorded on the diary cards.
Pruritus outcomes assessed by a composite score based on the behaviors displayed by the children as recorded on the diary cards.
Time frame: Assessments will be performed at planned visits on days 0, 3, 7, 10, 14, and daily via diary cards.
Safety of oral ivermectin measures by percentage of children with abnormal biochemistry laboratory value
Biochemistry laboratory value, including Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT), creatinine, and total bilirubin.
Time frame: Assessments will be performed at planned visits on days 0, 3, 7, 10, 14
Safety of oral ivermectin measures by percentage of children with abnormal hematology laboratory value
Hematology laboratory value including white blood cells, platelets, neutrophils, lymphocytes reported, hemoglobin, and hematocrit
Time frame: Assessments will be performed at planned visits on days 0, 3, 7, 10, 14
Safety of oral ivermectin as measured by percentage of children with abnormal neurological test result.
Neurological test assesses by responses to a battery of stimuli with responses recorded as normal or abnormal.
Time frame: Assessments will be performed at planned visits on days 0, 3, 7, 10, 14.
Acceptability of pediatric oral ivermectin assessed by score of assessment tools called ClinSearch Acceptability Score Test (CAST)
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ClinSearch Acceptability Score Test (CAST) reports a barycenter and its 90% confidence ellipses on a 3D-map to assess positive
Time frame: Days 0, 7
Efficacy of pediatric oral ivermectin to treat scabies in children <15 kg as measured by scabies lesion counts
Time frame: Days 0, 7, 14