Survey of Human Rabies Immune Globulin Safety in Children

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Brief Title

Survey of Human Rabies Immune Globulin Safety in Children

Official Title

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

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.

Study Type

Observational

Primary Outcome

Incidence of local and systemic adverse events (AEs) within 2 days of HRIG 300 IU/mL administration

Secondary Outcome

 Cumulative incidence of all local and systemic AEs within 10 days of HRIG 300 IU/mL administration

Condition

Rabies

Intervention

Human rabies immune globulin 300 IU/mL

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

50

Start Date

May 2022

Completion Date

July 2024

Primary Completion Date

June 2024

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

Gender

All

Ages

N/A - 17 Years

Contacts

Michael Sirimaturos, PharmD, 346-356-1692, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT05382650

Organization ID

PRO00028137

Responsible Party

Principal Investigator

Study Sponsor

The Methodist Hospital Research Institute

Collaborators

 Grifols Biologicals, LLC

Study Sponsor

Michael Sirimaturos, PharmD, Principal Investigator, The Methodist Hospital Research Institute

Verification Date

May 2022