A Study to Learn About the Amount of the Study Medicine (Sisunatovir) in Blood and
Its Safety in Infants and Children With Pneumonia Caused by RSV
Research Question:
Is the drug, Sisunatovir, safe in children who have a chest infection caused by RSV?
Basic Study Information
Purpose:
The purpose of the study is to learn about the safety and amount of sisunatovir in
the blood
of infants and children up to age 60 months. These children have Lower Respiratory
Tract
Infection (LRTI) caused by Respiratory Syncytial Virus (RSV). LRTI is the infection
to the
lower airways such as lungs.
This study will help inform the amount of sisunatovir to be used in future studies
of
sisunatovir in children.
This study is seeking for participants who:
- Are 1 day to less than or equal to 60 months of age
- weigh more than or equal to 2.5 kilograms to less than or equal to 23 kilograms.
- Have been tested to have RSV by medical tests.
- show signs of LRTI.
Up to 7 visits are required for the study. Some of these visits include checking participants
health over the phone and/or a visit at home.
Location: University of Rochester Medical Center
Study Reference #: STUDY00008652
Lead Researcher (Principal Investigator)
Lead Researcher:
Jennifer Nayak
Study Contact Information
Study Coordinator: Michelle Heiman
Phone: (585) 275-2107
Email: michelle_heiman@urmc.rochester.edu
Additional Study Details
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