Survey of Human Rabies Immune Globulin Safety in Children

Sponsor

The Methodist Hospital Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05382650

Collaborator

Grifols Biologicals, LLC (Industry)

Enrollment

Location

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rabies Rabies Human Rabies Virus Infection Pediatrics	Biological: Human rabies immune globulin 300 IU/mL

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 17 Years

Sexes Eligible for Study:

All

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