Pediatrics, Rabies, Rabies Human, Rabies Virus Infection
Conditions
Keywords
Pediatrics, Rabies post-exposure prophylaxis, Rabies PEP, Rabies immune globulin, Rabies IG, Adverse events
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 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.
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 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.
Interventions
BIOLOGICALHuman rabies immune globulin 300 IU/mL
All participants in this single-cohort observational study will receive human rabies immune globulin 300 IU/mL at a dose of 20 IU/kg per standard of care.
Sponsors
Grifols Biologicals, LLC
The Methodist Hospital Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of local and systemic adverse events (AEs) within 2 days of HRIG 300 IU/mL administration | Within 2 days of HRIG 300 IU/mL administration | Proportion of patients with 1 or more AEs deemed as possibly/definitely related to HRIG 300 IU/mL administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of all local and systemic AEs within 10 days of HRIG 300 IU/mL administration | Within 10 days of HRIG 300 IU/mL administration | Proportion of patients with 1 or more AEs deemed as possibly/definitely related to HRIG 300 IU/mL administration |
| Cumulative incidence of all local and systemic AEs within 30 days of HRIG 300 IU/mL administration | Within 30 days of HRIG 300 IU/mL administration | Proportion of patients with 1 or more AEs deemed as possibly/definitely related to HRIG 300 IU/mL administration |
| Cumulative incidence of all local and systemic serious adverse events (SAEs) within 30 days of HRIG 300 IU/mL administration | Within 30 days of HRIG 300 IU/mL administration | Proportion of patients with 1 or more SAE deemed as possibly/definitely related to HRIG 300 IU/mL administration. An AE is considered serious if any of the following outcomes occur: * Death * Life-threatening AE (life-threatening in the definition of serious refers to an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe) * In-patient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * An important medical event (refers to events which may not be immediately life-threatening, or result in death, or hospitalization, but from medical and scientific judgment, may jeopardize the participant or/and may require medical or surgical intervention to prevent one of the other outcomes listed above). |
| Type and severity of individual local and systemic AEs detected within 30 days of HRIG 300 IU/mL administration | Within 30 days of HRIG 300 IU/mL administration | Proportions of AEs that are local vs systemic and proportions of AEs that are mild, moderate, or severe among AEs deemed as possibly/definitely related to HRIG 300 IU/mL administration |
Countries
United States
Outcome results
None listed