Survey of Human Rabies Immune Globulin Safety in Children

Status Recruiting

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

Clinical Trial Details

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

View Details

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
Completed	`NCT04301206` - Videos and Simple Text to Empower Parents to Handle Their Sick Children	N/A
Not yet recruiting	`NCT04087070` - Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia
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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.