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Evaluating Pediatric Ivermectin in Children Under 15 kg (EPIC-15)

NCT06404333 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-12-18

No results posted yet for this study

Summary

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

Conditions

  • Scabies

Interventions

DRUG

CHILD-IVITAB

Ivermectin (200 µg/kg) oro-dispersible minitablets

DRUG

CHILD-IVITAB

Ivermectin (400 µg/kg) oro-dispersible minitablets

Sponsors & Collaborators

  • Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

    collaborator OTHER

  • Fundação de Dermatologia Tropical e Venereologia Alfredo da Matta (FUAM)

    collaborator UNKNOWN

  • University of Basel

    collaborator OTHER

  • ClinSearch

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Lorenz von Seidlein, Dr · Mahidol Oxford Tropical Medicine Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-25
Primary Completion
2025-11-30
Completion
2025-11-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06404333 on ClinicalTrials.gov