A Study for Early Diagnosis of RSV in Paediatric Participants
Research type
Research Study
Full title
A Two-Part Study With a Birth Cohort (Observational Stage) for Early Diagnosis of Respiratory Syncytial Virus (RSV), Followed by an Optional Phase 2a, Randomized, Double-blind, Placebo-controlled Study (Interventional Stage) to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 in Infants With Acute Respiratory Tract Infection due to RSV
IRAS ID
269112
Contact name
John Tsun Fai Ho
Contact email
Sponsor organisation
Janssen-Cilag Limited
Eudract number
2019-001509-25
Duration of Study in the UK
0 years, 8 months, 22 days
Research summary
This is a 2-stage research study where the purpose of the first stage (the observation stage) is to see if we can detect the early symptoms of Respiratory Syncytial Virus (RSV) in children from 28 days but less than 4 months old using an electronic mobile application installed on the child’s parent/caregivers own mobile device. This App will prompt the parent/caregiver to answer questions regarding any symptoms that the child may be experiencing. The second stage (the interventional stage) of the study is to see how well and how safely a study medication (called ‘JNJ-53718678’) works in these children, who have tested positive for an RSV infection. The study compares two treatments: a dose of JNJ-53718678 and a dummy medicine (or ‘placebo’), the dose administered will be based on the child’s weight and age and it will be decided by chance which treatment they receive. Both treatments are liquids given over 7 days (once a day) using an oral dosing syringe.
For both stages of the study the parent will need to sign an Informed consent form. For the observational stage after eligibility has been confirmed no tests will need to be performed other than the parents answering the questions on the mobile phone app, but if the parent receives an alert of a possible RSV infection they will need to take a nasal swab sample from their child. The sample will be used by the research site to confirm if the child does have the RSV infection. Once confirmed the parent can decide if they wish their child to enter the interventional stage by signing the second informed consent form. The child will undergo various test and assessments to ensure their eligibility, these include nasal swabs, an electrocardiogram, blood and urine test.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
19/NW/0510
Date of REC Opinion
16 Aug 2019
REC opinion
Favourable Opinion