Status:
TERMINATED
Survey of Human Rabies Immune Globulin Safety in Children
Lead Sponsor:
The Methodist Hospital Research Institute
Collaborating Sponsors:
Grifols Biologicals, LLC
Conditions:
Rabies
Rabies Human
Eligibility:
All Genders
Up to 17 years
Brief 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 Sta...
Detailed Description
BACKGROUND: Rabies PEP consists of thorough wound cleansing, administration of HRIG 20 IU/kg body weight, and 4 to 5 doses of rabies vaccine. The safety of HRIG 300 IU/mL has been confirmed only for a...
Eligibility Criteria
Inclusion
- 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
- Legally authorized representative (parent) and/or patient declined participation
- Administration sites for HRIG are unknown
Exclusion
Key Trial Info
Start Date :
February 22 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 15 2025
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05382650
Start Date
February 22 2023
End Date
October 15 2025
Last Update
November 13 2025
Active Locations (2)
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1
Houston Methodist
Houston, Texas, United States, 77030
2
Texas Children's Hospital
Houston, Texas, United States, 77030