A Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected With Respiratory Syncytial Virus

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Respiratory Syncytial Viruses

In brief

The purpose of this study is to determine in hospitalized infants and children who are infected with respiratory syncytial virus (RSV) the dose-response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal RSV shedding using quantitative real-time reverse transcriptase polymerase chain reaction (qRT-PCR).

Key facts

Study ID

NCT03333317

Run by

Janssen Research & Development, LLC

People needed

7

Starts

2017-11-24

Expected to finish

2018-03-23

Last updated by the study team

2019-12-23

Who can join

Age: 0 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants hospitalized (or in emergency room [ER]) at the time of randomization and unlikely to be discharged for the first 24 hours after randomization
• Participants diagnosed with respiratory syncytial virus (RSV) infection using a polymerase chain reaction (PCR)-based molecular diagnostic assay, with or without co-infection with another respiratory pathogen (respiratory virus or bacteria)
• Participants who have an acute respiratory illness with signs and symptoms consistent with a viral infection (for example, fever, cough, nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset less than or equal to <=5 days from the anticipated time of randomization. Onset of symptoms is defined as the first time (within 1 hour) the parent(s)/caregiver(s) becomes aware of respiratory or systemic symptoms of RSV infection
• With the exception of the symptoms related to the RSV infection or defined comorbid condition for severe RSV disease (prematurity at birth [participant's gestational age was less than {<}37 weeks; for infants <1 year old at randomization], bronchopulmonary dysplasia, congenital heart disease, other congenital diseases, Down syndrome, neuromuscular impairment, or cystic fibrosis), participant must be medically stable on the basis of physical examination, medical history, vital signs/peripheral capillary oxygen saturation (SpO2), and electrocardiogram (ECG) performed at screening. If there are abnormalities, they must be consistent with the underlying condition in the study population and/or the RSV infection. This determination must be recorded in the participant's source documents and initialed by the investigator. Participants with comorbidities will be allowed to be enrolled once the Independent Data Monitoring Committee (IDMC) has reviewed the pharmacokinetic (PK) and safety data of the highest dose that will be used in this study and once the IDMC has recommended opening recruitment to this group. Sites will be notified when the restriction is lifted
• The participant's estimated glomerular filtration rate (eGFR) is not below the lower limit of normal for the participant's age

You may not qualify if…

• Participants who are not expected to survive for more than 48 hours
• Participants who have had major thoracic or abdominal surgery in the 6 weeks prior to randomization
• Participants who have a known or suspected immunodeficiency (except immunoglobulin A [IgA] deficiency), such as a known human immunodeficiency virus infection
• Participants being treated with extracorporeal membrane oxygenation
• Participant receiving chronic oxygen therapy at home prior to admission
• Participants who have a poorly functioning gastrointestinal tract (that is, unable to absorb drugs or nutrition via enteral route)

Where it is running

• MemorialCare Research Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States
• The Children's Mercy Hospital — Kansas City, Missouri, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Jacobi Medical Center — The Bronx, New York, United States
• West Virginia University — Morgantown, West Virginia, United States
• American Family Children's Hospital — Madison, Wisconsin, United States
• Huderf — Brussels, Belgium
• McMaster Children's Hospital — Hamilton, Ontario, Canada
• Heim Pal Gyermekkorhaz, Borgyogyaszati Osztaly — Budapest, Hungary
• Velkey László Gyermekegészségügyi Központ — Miskolc, Hungary
• Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz — Nyíregyháza, Hungary
• National Hospital Organization Fukuoka Hospital — Fukuoka, Japan
• Fukuoka Children's Hospital — Fukuoka, Japan
• National Hospital Organization Fukuyama Medical Center — Fukuyama, Japan
• Fukuyama City Hospital — Fukuyama, Japan
• JA Hiroshima General Hospital — Hatsukaichi, Japan
• Hirosaki National Hospital — Hirosaki, Japan
• National Hospital Organization Kanazawa Medical Center — Kanazawa, Japan
• National Hospital Organization Kokura Medical Center — Kitakyushu, Japan
• National Hospital Organization Niigata National Hospital — Niigata, Japan
• Nakano Children's Hospital — Osaka, Japan
• Takatsuki General Hospital — Osaka, Japan
• NHO Beppu Medical Center — Ōita, Japan
• Ota Memorial Hospital — Ōta-ku, Japan
• NHO Saitama National Hospital — Saitama, Japan

Full record on ClinicalTrials.gov

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