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, Japan, South Africa10 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 range

1 Day – 60 Months

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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