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

Last updated: April 21, 2025
Sponsor: Pfizer
Overall Status: Terminated

Phase

1

Condition

Respiratory Syncytial Virus (Rsv) Infection

Treatment

Placebo

Active

Clinical Study ID

NCT06102174
C5241009
2023-504425-39-00
  • Ages 1-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 ofscreening

  • Suspected or confirmed clinically significant moderate or severe bacterial infectionthat may interfere with the evaluation of response to the study intervention

  • Known to have significant comorbidities that would limit the ability to administerthe study intervention or evaluate the safety or clinical response to the studyintervention

Study Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
February 15, 2024
Estimated Completion Date:
September 03, 2024

Connect with a study center

  • Hospital Italiano Regional del Sur

    Bahia Blanca, Buenos Aires 8000
    Argentina

    Site Not Available

  • Clinica Privada del Sol S.A

    Cordoba, Córdoba X5000IIH
    Argentina

    Site Not Available

  • Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L

    San Miguel de Tucuman, Tucumán 4000
    Argentina

    Site Not Available

  • Hospital del Nino Jesus

    San Miguel de Tucumán, Tucumán 4000
    Argentina

    Site Not Available

  • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

    Buenos Aires, 1426
    Argentina

    Site Not Available

  • Children's & Women's Health Centre of British Columbia

    Vancouver, British Columbia V6H 3N1
    Canada

    Site Not Available

  • The Hospital For Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • Royal University Hospital

    Saskatoon, Saskatchewan S7N 0W8
    Canada

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, Hamerkaz 5262100
    Israel

    Site Not Available

  • Yitzhak Shamir Medical Center

    Zerifin, Hamerkaz 70300
    Israel

    Site Not Available

  • Rambam Health Care Campus

    Haifa, Hatsafon 3109601
    Israel

    Site Not Available

  • Research Unit / Children A Department

    Haifa, Ḥeifā 3109601
    Israel

    Site Not Available

  • Kojunkai Daido Hospital

    Nagoya, Aichi 457-8511
    Japan

    Site Not Available

  • National Hokkaido Medical Center

    Sapporo, Hokkaido 063-0005
    Japan

    Site Not Available

  • National Hospital Organization Kanazawa Medical Center

    Kanazawa, Ishikawa 920-8650
    Japan

    Site Not Available

  • National Hospital Organization Shikoku Medical Center for Children and Adults

    Zentsuji, Kagawa 765-8507
    Japan

    Site Not Available

  • Nintenkai Kagoshima Children's Hospital

    Hioki, Kagoshima 899-2503
    Japan

    Site Not Available

  • National Hospital Organization Mie Chuo Medical Center

    Tsu, MIE 514-1101
    Japan

    Site Not Available

  • Yamanashi Prefectural Central Hospital

    Kofu, Yamanashi 400-8506
    Japan

    Site Not Available

  • Osaka City General Hospital

    Osaka, 534-0021
    Japan

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam, Kyǒnggi-do 13620
    Korea, Republic of

    Site Not Available

  • Korea University Anam Hospital

    Seoul, Seoul-teukbyeolsi [seoul] 02841
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [seoul] 03080
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [seoul] 03722
    Korea, Republic of

    Site Not Available

  • Monti Clinical Research Centre

    Mdantsane, Eastern CAPE 5219
    South Africa

    Site Not Available

  • Worthwhile Clinical Trials

    Benoni, Gauteng 1500
    South Africa

    Site Not Available

  • University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA)

    Johannesburg, Gauteng 2013
    South Africa

    Site Not Available

  • Hsinchu Municipal Mackay Children's Hospital

    Hsinchu City, Hsinchu 30046
    Taiwan

    Site Not Available

  • Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

    Hualien City, Hualien 970
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333
    Taiwan

    Site Not Available

  • University of Alabama at Birmingham - School of Medicine

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • Kaiser Permanente

    Los Angeles, California 90027
    United States

    Site Not Available

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California 90027
    United States

    Site Not Available

  • Children's Hospital of Orange County

    Orange, California 92868
    United States

    Site Not Available

  • UC Davis Medical Center Ambulatory Care Center

    Sacramento, California 95817
    United States

    Site Not Available

  • UC Davis Medical Center, Department of Infectious Diseases

    Sacramento, California 95817
    United States

    Site Not Available

  • University of California Davis Health

    Sacramento, California 95817
    United States

    Site Not Available

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Yale Center for Clinical Investigations

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Yale University School of Medicine

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Yale-New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • C.S. Mott Children's Hospital

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Hackensack University Medical Center Joseph M. Sanzari Children's Hospital

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Rutgers Robert Wood Johnson Medical School

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Rutgers University

    New Brunswick, New Jersey 08903
    United States

    Site Not Available

  • Advanced Specialty Care

    Commack, New York 11725
    United States

    Site Not Available

  • Stony Brook Medicine Clinical Research Center

    East Setauket, New York 11733
    United States

    Site Not Available

  • Child Health Care Associates

    East Syracuse, New York 13057
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • Stony Brook University

    Stony Brook, New York 11794-8111
    United States

    Site Not Available

  • CIncinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Cyn3rgy Research

    Gresham, Oregon 97030
    United States

    Site Not Available

  • Christus Children's

    San Antonio, Texas 78207
    United States

    Site Not Available

  • Intermountain - Primary Children's Hospital

    Salt Lake City, Utah 84113
    United States

    Site Not Available

  • Seattle Children's - Building Cure

    Seattle, Washington 98101
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

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