Survey of Human Rabies Immune Globulin Safety in Children

Launched by THE METHODIST HOSPITAL RESEARCH INSTITUTE · May 16, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a treatment called human rabies immune globulin (HRIG) in children who may have been exposed to rabies. The trial is taking place in various emergency departments across the Houston Methodist system and other sites in the United States. It aims to find out how safe the HRIG 300 IU/mL product is when given to children aged 17 and younger as part of their treatment for rabies exposure.

To be eligible for this study, children must have received the HRIG treatment during an emergency department visit. However, there are some important criteria that could exclude them, such as if they received an incorrect dose or have had previous rabies vaccinations. If they join the study, participants may be asked to provide information about their health and any reactions they might have to the treatment. The results of this study will help ensure safe care for children at risk of rabies.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 1. Received HRIG 300 IU/mL for rabies PEP during an ED encounter visit
• • 2. Aged ≤17 years
• • Exclusion Criteria
• • 1. HRIG 300 IU/mL dose given is \<18 IU/kg or \>22 IU/kg
• • 2. Patient is admitted or transferred to a hospital from the ED for further management of injuries related to the animal exposure
• • 3. Patient has a history of rabies vaccine or rabies immune globulin administration
• • 4. Legally authorized representative (parent) does not speak English if patient is \<7 years old
• • 5. Legally authorized representative (parent) or patient does not speak English if patient is 7 to 17 years old
• • 6. Inability to obtain consent
• • 1. More than 3 days passed since HRIG 300 IU/mL administration prior to screen
• • 2. Unable to contact legally authorized representative (parent) and/or patient within 3 days of HRIG 300 IU/mL administration
• • 3. Legally authorized representative (parent) and/or patient declined participation
• • 7. Administration sites for HRIG are unknown