Status:
TERMINATED
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
Lead Sponsor:
Pfizer
Conditions:
Respiratory Syncytial Virus Infections
Eligibility:
All Genders
1-60 years
Phase:
PHASE1
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) c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06102174
Start Date
February 15 2024
End Date
September 3 2024
Last Update
December 30 2025
Active Locations (9)
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1
Kaiser Permanente Los Angeles Medical center
Los Angeles, California, United States, 90027
2
Kaiser Permanente
Los Angeles, California, United States, 90027
3
Washington University School of Medicine
St Louis, Missouri, United States, 63110
4
Kojunkai Daido Hospital
Nagoya, Aichi-ken, Japan, 457-8511