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

Pfizer

Status and phase: Enrolling; Phase 1

Conditions: Respiratory Syncytial Virus Infections

Treatments: Drug: Placebo; Drug: Active

Study type: Interventional

Funder types: Industry

Identifiers

NCT06102174

C5241009

2023-504425-39-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 1 day to 60 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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108 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Oral or Nasogastric tube (NG)

Treatment:

Drug: Placebo

Sisunatovir

Active Comparator group

Description:

Oral or NG tube

Treatment:

Drug: Active