Respiratory Syncytial Virus Infections
Conditions
Interventions
Group 1
20 receive the active drug, initial doses of 2mg / kg to 18mg / kg
and 4 receive placebo
oral administraion
for 7 days
Group 2
20 receive the active drug, initial doses of 1.5mg / kg to 13,5mg / kg and 4 receive placeb, oral administraio
for 7 days
Group 3
20 receive the active drug
Initial doses of 1mg / kg to 9 mg / kg
oral administraio
Drug
Sponsors
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo - HCFMRP-USP
Janssen-Cilag Farmacêutica Ltda.
Eligibility
Age
1 Months to 24 Months
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Participant has presented at the hospital for suspected Respiratory Syncytial Virus (RSV) infection within 72 hours prior to Screening completion; Participant has been hospitalized for this suspected RSV infection; Participant has been diagnosed with RSV infection using a polymerase chain reaction (PCR)-based assay, preferably commercially available locally; Participant was born after a normal term pregnancy (greater than or equal to 37 weeks and 0 days); A legally acceptable representative of the participant must sign an Informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, are willing for their child to participate in the study, are willing for their child to remain in the hospital for the first 3 days of dosing (even if not clinically indicated), and are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Participant who had major surgery within the 28 days prior to randomization or planned major surgery through the course of the study; Participant has major congenital anomalies or known cytogenetic disorders; Participant has known or suspected immunodeficiency, such as known human immunodeficiency virus (HIV) infection; Participant has known or suspected hepatitis B or C infection; Participant is upon current admission initially hospitalized in the Intensive care unit (ICU) and/or in need of invasive endotracheal mechanical ventilation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) of JNJ- 53718678 - The Cmax is the maximum observed plasma concentration.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants Reaching Undetectability of virus Between First Administration of Study Drug and Day 28 - Non-detectability of virus in nasal swabs between first administration of study drug and Day 28 will be reported.;;Total Number of Respiratory Syncytial Virus (RSV) Hospitalization Days from Admission to Discharge - The total number of Respiratory Syncytial Virus (RSV) hospitalization days from admission to discharge will be reported.; ; Changes in Peripheral Capillary Oxygen Saturation (SpO2) - The Percentage of Peripheral Capillary Oxygen Saturation (SpO2) will be assessed by the investigator during hospitalisation.; ;Total Apparent Clearance (CL/F) of JNJ-53718678 - Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.; ;Area Under the Viral Load-time Curve (VL AUC) - VL will be determined by quantitative real-time reverse transcriptasepolymerase chain reaction (qRT-PCR) assay of nasal swabs. The VL AUC (copies. hour/ml) will be calculated based on the trapezoidal method;;Trough Plasma Concentration (Ctrough) of JNJ-53718678 - The Ctrough is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen.; ;Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) - The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval.;;Apparent Volume of Distribution (Vd/F) of JNJ-53718678 - Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vd/F) is influenced by t | — |
Countries
Argentina, Belgium, Brazil, Germany, Spain, Sweden
Contacts
Public ContactVinicius Righi
Janssen-Cilag Farmacêutica Ltda.
Outcome results
None listed