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

Respiratory Syncytial Virus Infections Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06102174
• Other study ID #: C5241009
• Secondary ID: 2023-504425-39-0
• Status: Recruiting
• Phase: Phase 1
• Start date: February 15, 2024
• Est. completion date: April 2, 2025

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: April 2, 2025
• Est. primary completion date: April 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 60 Months

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Respiratory Syncytial Virus Infections
• Respiratory Tract Infections

Intervention

Drug:
• Placebo
Placebo
• Active
Sisunatovir

Locations

Country	Name	City	State
Argentina	Hospital Italiano Regional del Sur	Bahia Blanca	Buenos Aires
Argentina	Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L	San Miguel de Tucuman	Tucumán
Argentina	Hospital del Nino Jesus	San Miguel de Tucumán	Tucumán
Canada	Children's & Women's Health Centre of British Columbia	Vancouver	British Columbia
Israel	Rambam Health Care Campus	Haifa	Hatsafon
Israel	Research Unit / Children A Department	Haifa	?eifa
Israel	Sheba Medical Center	Ramat Gan	Hamerkaz
Israel	Yitzhak Shamir Medical Center	Zerifin	Hamerkaz
Japan	Nintenkai Kagoshima Children's Hospital	Hioki	Kagoshima
Japan	National Hospital Organization Kanazawa Medical Center	Kanazawa	Ishikawa
Japan	Yamanashi Prefectural Central Hospital	Kofu	Yamanashi
Japan	Kojunkai Daido Hospital	Nagoya	Aichi
Japan	Osaka City General Hospital	Osaka
Japan	National Hokkaido Medical Center	Sapporo	Hokkaido
Japan	National Hospital Organization Mie Chuo Medical Center	Tsu	MIE
Japan	National Hospital Organization Shikoku Medical Center for Children and Adults	Zentsuji	Kagawa
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Kyonggi-do
Korea, Republic of	Korea University Anam Hospital	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul	Seoul-teukbyeolsi [seoul]
South Africa	Worthwhile Clinical Trials	Benoni	Gauteng
South Africa	University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA)	Johannesburg	Gauteng
United States	C.S. Mott Children's Hospital	Ann Arbor	Michigan
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Michigan	Ann Arbor	Michigan
United States	Children's Hospital Colorado	Aurora	Colorado
United States	University of Chicago Medical Center	Chicago	Illinois
United States	CIncinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Advanced Specialty Care	Commack	New York
United States	Stony Brook Medicine Clinical Research Center	East Setauket	New York
United States	Child Health Care Associates	East Syracuse	New York
United States	Cyn3rgy Research	Gresham	Oregon
United States	Hackensack University Medical Center Joseph M. Sanzari Children's Hospital	Hackensack	New Jersey
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Kaiser Permanente	Los Angeles	California
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey
United States	Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Rutgers University	New Brunswick	New Jersey
United States	Rutgers University	New Brunswick	New Jersey
United States	Children's Hospital of Orange County	Orange	California
United States	University of Rochester Medical Center	Rochester	New York
United States	UC Davis Medical Center Ambulatory Care Center	Sacramento	California
United States	UC Davis Medical Center, Department of Infectious Diseases	Sacramento	California
United States	University of California Davis Health	Sacramento	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Intermountain - Primary Children's Hospital	Salt Lake City	Utah
United States	Christus Children's	San Antonio	Texas
United States	Seattle Children's - Building Cure	Seattle	Washington
United States	Seattle Children's Hospital	Seattle	Washington
United States	Stony Brook University	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Israel,  Japan,  Korea, Republic of,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment Emergent Adverse Events (TEAEs)		Day 1 to Day 33
Primary	Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) leading to discontinuations		Day 1 to Day 33
Primary	Incidence of clinically significant abnormal laboratory values		Day 1 to Day 33
Primary	Incidence of clinically significant abnormal vital signs.		Day 1 to Day 33
Secondary	Plasma concentrations of sisunatovir at steady state (Day 3 or later).		Day 3 to Day 5

External Links

•   To obtain contact information for a study center near you, click here.