Survey of Human Rabies Immune Globulin Safety in Children

Description

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.

Conditions

Rabies, Rabies Human, Rabies Virus Infection, Pediatrics

Study Overview

Study Details

Study overview

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.

Multicenter Safety Evaluation of Human Rabies Immune Globulin 300 IU/mL in Children

Survey of Human Rabies Immune Globulin Safety in Children

Condition
Rabies
Intervention / Treatment

-

Contacts and Locations

Houston

Houston Methodist, Houston, Texas, United States, 77030

Houston

Texas Children's Hospital, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    to 17 Years

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    The Methodist Hospital Research Institute,

    Michael Sirimaturos, PharmD, PRINCIPAL_INVESTIGATOR, The Methodist Hospital Research Institute

    Study Record Dates

    2024-07