Evaluating the safety of rabies immune globulin in children

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

This study is testing the safety of a rabies treatment for children who have been exposed to the virus to see if it causes any side effects.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: N/A to 17 Years
• Sex: All
• Sponsor: The Methodist Hospital Research Institute (Academic / other)
• Locations: 2 sites (Houston, Texas and 1 other locations)
• Trial ID: NCT05382650 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the safety of human rabies immune globulin (HRIG) 300 IU/mL in pediatric patients receiving rabies post-exposure prophylaxis (PEP) in emergency departments. Conducted across the Houston Methodist system and additional sites in the U.S., the study will collect safety data through surveys and health record reviews for up to 30 days following HRIG administration. Participants will be monitored for adverse events through structured surveys conducted at specified intervals after treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are pediatric patients aged 17 years or younger who receive HRIG 300 IU/mL for rabies PEP during an emergency department visit.

Not a fit: Patients who have received a different dose of HRIG or have a history of rabies vaccine or immune globulin administration may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide critical safety data for the use of HRIG in children, ensuring safer rabies PEP protocols.

How similar studies have performed: While the safety of HRIG has been established in adults, this study is novel as it specifically evaluates its safety in the pediatric population.

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

Where this trial is running

Houston, Texas and 1 other locations

• Houston Methodist — Houston, Texas, United States (Recruiting)
• Texas Children's Hospital — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Michael Sirimaturos, PharmD — The Methodist Hospital Research Institute
• Study coordinator: Michael Sirimaturos, PharmD

Conditions Rabies; Rabies Human; Rabies Virus Infection; Pediatrics; Rabies post-exposure prophylaxis; Rabies PEP; Rabies immune globulin; Rabies IG