TerminatedPhase 1

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

Stopped: Study discontinued due to business reasons. There were no safety concerns in the decision to stop study and no changes to sponsor's assessment of the risk-benefit profile for participants who received sisunatovir in the study

United States, Japan10 participantsStarted 2024-02-15

Plain-language 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.

Who can participate

Age range1 Day – 60 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Timeframe: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days)

Number of Participants Who Discontinued From Study Due to TEAEs

Timeframe: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days)

Number of Participants Who Discontinued From Study Due to Serious TEAEs

Timeframe: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days)

Number of Participants With Clinically Significant Laboratory Abnormalities

Timeframe: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days)

Number of Participants With Clinically Significant Vital Signs

Timeframe: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days)

Trial details

NCT IDNCT06102174

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09-03

Results submitted2025-08-25

View on ClinicalTrials.gov More Respiratory Syncytial Virus Infections trials