Survey of Human Rabies Immune Globulin Safety in Children

The Methodist Hospital Research Institute (TMHRI)

Status: Enrolling

Conditions: Pediatrics; Rabies Human; Rabies Virus Infection; Rabies

Treatments: Biological: Human rabies immune globulin 300 IU/mL

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05382650

PRO00028137

Details and patient eligibility

About

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.

Full 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 adult patients. Although the safety of HRIG 300 IU/mL in the pediatric population has not been fully established, there is no age limit on the FDA approved indication for HRIG 300 IU/mL, and it is routinely administered to pediatric patients as standard of care in the United States.

STUDY DESIGN: This observational, multicenter, prospective study will collect information on safety events that occur up to 30 days after standard of care administration of HRIG 300 IU/mL among pediatric patients (age ≤17 years) at up to 5 study sites in the United States. Safety data will be collected using surveys and chart review of the health record. All participants will receive HRIG 300 IU/mL per standard of care prior to joining this study. The day of HRIG 300 IU/mL administration will be defined as day 0. The study will conduct Survey 1 on day 2 and Survey 2 on day 10 to collect information on adverse events (AEs). Investigators will review the electronic health record on day 30 to collect additional information on AEs. If a serious adverse event is detected during Survey 1, Survey 2, or the 30-day chart review and is not previously documented as being resolved or stabilized the study will conduct Survey 3 on day 30.

Enrollment: 50 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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