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
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- Drug: PlaceboDrug: Active
- Registration Number
- NCT06102174
- Lead Sponsor
- Pfizer
- Brief Summary
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.
All participants in the study will receive many amounts of sisunatovir or placebo. Placebo is a pill that does not have any medicine in it.
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.
The study will compare the experiences of infants and children receiving sisunatovir to identify the amount of sisunatovir to be used in future studies in infants and children.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
- 1 day to β€60 months of age and weight β₯2.5 kg to β€23 kg
- Positive RSV diagnostic test, antigen or molecular test
- Evidence of Lower Respiratory Tract Infection (LRTI)
- Premature infants (gestational age less than 35 weeks) AND <1 year of post-natal age
- Neonates with intrauterine growth restriction
- Expected to receive an antiviral for another viral infection within 10 days of screening
- Suspected or confirmed clinically significant moderate or severe bacterial infection that may interfere with the evaluation of response to the study intervention
- Known to have significant comorbidities that would limit the ability to administer the study intervention or evaluate the safety or clinical response to the study intervention
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Oral or Nasogastric tube (NG) Sisunatovir Active Oral or NG tube
- Primary Outcome Measures
Name Time Method Incidence of Treatment Emergent Adverse Events (TEAEs) Day 1 to Day 33 Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) leading to discontinuations Day 1 to Day 33 Incidence of clinically significant abnormal laboratory values Day 1 to Day 33 Incidence of clinically significant abnormal vital signs. Day 1 to Day 33
- Secondary Outcome Measures
Name Time Method Plasma concentrations of sisunatovir at steady state (Day 3 or later). Day 3 to Day 5
Trial Locations
- Locations (9)
Kaiser Permanente Los Angeles Medical Center
πΊπΈLos Angeles, California, United States
Kaiser Permanente
πΊπΈLos Angeles, California, United States
Washington University School of Medicine
πΊπΈSaint Louis, Missouri, United States
Kojunkai Daido Hospital
π―π΅Nagoya, Aichi, Japan
Nintenkai Kagoshima Children's Hospital
π―π΅Hioki, Kagoshima, Japan
Yamanashi Prefectural Central Hospital
π―π΅Kofu, Yamanashi, Japan
Osaka City General Hospital
π―π΅Osaka, Japan
Monti Clinical Research Centre
πΏπ¦Mdantsane, Eastern CAPE, South Africa
University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA)
πΏπ¦Johannesburg, Gauteng, South Africa