Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05382650
Study type Observational
Source The Methodist Hospital Research Institute
Contact Michael Sirimaturos, PharmD
Phone 346-356-1685
Email mwsirimaturos@houstonmethodist.org
Status Recruiting
Phase
Start date February 22, 2023
Completion date July 2024

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05975658 - WIReD: Wireless Interstage Remote Device Study
Completed NCT03921346 - Reducing Prehospital Medication Errors & Time to Drug Delivery by EMS During Simulated Pediatric CPR N/A
Not yet recruiting NCT04087070 - Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia
Completed NCT04301206 - Videos and Simple Text to Empower Parents to Handle Their Sick Children N/A
Recruiting NCT06273228 - Parenting Young Children in Pediatrics N/A
Recruiting NCT05480930 - Improving Nighttime Access to Care and Treatment; Part 4-Haiti N/A
Not yet recruiting NCT05815563 - Validation of Peripheral Perfusion Index in Predicting Successful Supraclavicular Brachial Plexus Block in Pediatrics
Recruiting NCT02556541 - Ultrasound-guided Peripheral Vascular Access in Children N/A
Recruiting NCT02908113 - Visual Perception in Preterm Infants N/A
Not yet recruiting NCT01678066 - A Prospective Study to Bilaterally Compare a Non-Invasive Cardiac Output Monitor N/A
Completed NCT04993599 - Evaluation of Social Robot Usability for Pediatric Patients and Carers N/A
Completed NCT05537168 - Bayesian Networks in Pediatric Cardiac Surgery
Completed NCT01603628 - BOTOX® Treatment in Pediatric Lower Limb Spasticity Phase 3
Completed NCT01603615 - BOTOX® Open-Label Treatment in Pediatric Upper Limb Spasticity Phase 3
Completed NCT06098105 - Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block vs Laparoscopic Intraperitoneal Instillation of Local Anesthetic in Pediatrics N/A
Completed NCT01418846 - Determination of Voriconazole Levels in Saliva - Validation in Specific Subsets of Patients N/A
Completed NCT01460329 - Comparing Cardiac Output Measurements in Critically Ill Children Using USCOM and Transthoracic ECHO N/A
Withdrawn NCT00666393 - An Evaluation of Safety of the Fentanyl Transdermal System for Management of Acute Post-Operative Pain in Pediatric Patients Phase 3
Recruiting NCT03337581 - Pharmacodynamics and Pharmacokinetics of Dexmedetomidine in Pediatric Phase 4
Recruiting NCT05275881 - Impact of Virtual Reality in Pediatric Hematology and Oncology N/A