Clinical trial NCT06102174: 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
Official title: AN INTERVENTIONAL, PHASE 1b, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, MULTI-CENTER, DOSE-FINDING STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF SISUNATOVIR IN PEDIATRIC PARTICIPANTS UP TO AGE 60 MONTHS WITH RESPIRATORY SYNCYTIAL VIRUS (RSV) LOWER RESPIRATORY TRACT INFECTION (LRTI)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Respiratory Syncytial Virus Infections
Keywords: Lower Respiratory Tract Infection
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-10-26
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* 1 day to ≤60 months of age and weight ≥2.5 kg to ≤23 kg
* Positive RSV diagnostic test, antigen or molecular test
* Evidence of Lower Respiratory Tract Infection (LRTI)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of Treatment Emergent Adverse Events (TEAEs)
timeFrame: Day 1 to Day 33
measure: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) leading to discontinuations
timeFrame: Day 1 to Day 33
measure: Incidence of clinically significant abnormal laboratory values
timeFrame: Day 1 to Day 33
measure: Incidence of clinically significant abnormal vital signs.
timeFrame: Day 1 to Day 33
Secondary outcomes:
measure: Plasma concentrations of sisunatovir at steady state (Day 3 or later).
timeFrame: Day 3 to Day 5
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Nagoya
country: Japan
facility: Kojunkai Daido Hospital
state: Aichi
city: Hioki
country: Japan
facility: Nintenkai Kagoshima Children's Hospital
state: Kagoshima
city: Kofu
country: Japan
facility: Yamanashi Prefectural Central Hospital
state: Yamanashi
city: Osaka
country: Japan
facility: Osaka City General Hospital
city: Mdantsane
country: South Africa
facility: Monti Clinical Research Centre
state: Eastern CAPE
city: Johannesburg
country: South Africa
facility: University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA)
state: Gauteng
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: