TerminatedNot Applicable

Survey of Human Rabies Immune Globulin Safety in Children

Stopped: Slow enrollment

United States35 participantsStarted 2023-02-22

Plain-language summary

This observational study will be conducted across the Houston Methodist system, including all hospital-based and freestanding emergency departments (ED), and up to 4 additional sites in the United States. The safety of human rabies immune globulin (HRIG) 300 IU/mL product (HyperRAB®) in pediatric patients has not been fully established. The purpose of this study is to evaluate the safety of HRIG 300 IU/mL when given to pediatric patients per standard of care for rabies postexposure prophylaxis (PEP) in the ED.

Who can participate

Age range17 Years

SexALL

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Inclusion criteria

✓. Received HRIG 300 IU/mL for rabies PEP during an ED encounter visit
✓. Aged ≤17 years

Exclusion criteria

✕. HRIG 300 IU/mL dose given is \<18 IU/kg or \>22 IU/kg
✕. Patient is admitted or transferred to a hospital from the ED for further management of injuries related to the animal exposure
✕. Patient has a history of rabies vaccine or rabies immune globulin administration
✕. Legally authorized representative (parent) does not speak English if patient is \<7 years old
✕. Legally authorized representative (parent) or patient does not speak English if patient is 7 to 17 years old
✕. Inability to obtain consent
✕. More than 3 days passed since HRIG 300 IU/mL administration prior to screen
✕. Unable to contact legally authorized representative (parent) and/or patient within 3 days of HRIG 300 IU/mL administration

What they're measuring

Incidence of local and systemic adverse events (AEs) within 2 days of HRIG 300 IU/mL administration

Timeframe: Within 2 days of HRIG 300 IU/mL administration

Trial details

NCT IDNCT05382650

SponsorThe Methodist Hospital Research Institute

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-09-17

View on ClinicalTrials.gov More Rabies trials