Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus Infection MedDRA version: 20.1 Level: LLT Classification code 10066740 Term: Acute respiratory tract infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 21.1 Level: PT Classification code 10061603 Term: Respiratory syncytial virus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Janssen Sciences Ireland UC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each potential subject must satisfy all of the following criteria to be enrolled in the study: 1. The subject is a boy or girl =28 days and =3 years at the time of consent. 2. Each subject’s legally acceptable representative (ie, parent(s)/legal guardian) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, is willing for their child to participate in the study, is willing for their child to remain in the hospital until at least Day 2 (even if not clinically indicated; Cohort 1 only), and is willing/able to adhere to the lifestyle restrictions specified in the protocol and study procedures and assessments to be performed by the parent(s)/caregiver(s) as well as those by the investigator/site staff. Note: Prior to signing the main consent form for the study, subject’s legally acceptable representative may specifically allow for the collection and testing of nasal mid - turbinate swab by signing the pre-screening (diagnostic) ICF. This is not required if a positive RSV diagnostic result based on a local SOC sample collected within 48 hours prior to anticipated randomization is available and used for determining study eligibility. 3. The subject has been diagnosed with RSV infection using a preferably rapid polymerase chain reaction (PCR) or other molecular-based diagnostic assay (preferred) or a rapid-antigen-detection assay. Note: If a subject had a positive similar RSV diagnostic test from another study for which (s)he was otherwise ineligible or a SOC test within 24 hours prior to start of screening and meets all eligibility criteria for inclusion in this study, this diagnostic test result can be used for confirmation of eligibility. Randomization should occur within 24 hours after start of screening or within 48 hours after collection of the SOC sample used for local RSV diagnosis, whichever comes first. Note: If a rapid-antigen-detection assay is used as part of SOC or study specifically (with the main study ICF or with the diagnostic ICF having been signed), the remainder of the screening sample used for the RSV diagnostic testing should be sent to the central laboratory for additional virologic analyses, as applicable. 4. Criterion modified per Amendment 6: 4.1 The subject has an acute respiratory illness with at least 1 of the signs/symptoms listed in each of the following categories within 24 hours prior to start of screening and at screening, as evaluated by the investigator: • URTI: nasal congestion, rhinorrhea, pharyngitis, or otitis media; AND • LRTI: increased respiratory effort (as evidenced by subcostal, intercostal or tracheosternal retractions, grunting, head bobbing, nasal flaring or tachypnea), abnormal breathing sounds (wheezing, rales or rhonchi), cyanosis, apnea, or cough (cough or wheezing should be accompanied by at least one additional LRTI sign/symptom in order to be eligible); AND • Systemic/general: feeding difficulties, defined as <75% intake of normal food amounts; dehydration; fever; disturbed sleep or disturbed activity level (irritable/restless/agitated/less responsive). 5. The time of onset of RSV symptoms to the anticipated time of randomization must be =5 days. Onset of symptoms is defined as the time of the day (or part of the day if time of the day cannot be specified) the parent(s)/caregiver(s) became(s) aware of the first sign and/or symptom consistent with respiratory or systemic/general manifestation of symptoms of R
Exclusion criteria
Exclusion criteria: Any potential subject who meets any of the following criteria will be excluded from participating in the study: 1. The subject is 450 ms per the machine read (mean of triplicate) parameter result confirmed by repeat triplicate ECG recording during screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish antiviral activity of JNJ-53718678 as measured by respiratory syncytial virus(RSV) viral load in nasal swab samples by a quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in children =28 days and =3 years of age with RSV disease.;Secondary Objective: To evaluate in children =28 days and =3 years of age with RSV disease: ? the dose-response relationship for antiviral activity of JNJ-53718678 ? the impact of JNJ-53718678 on the clinical course of RSV infection ? the safety and tolerability of JNJ-53718678 after repeated oral doses ? the pharmacokinetics (PK) of JNJ-53718678 after repeated oral doses ? medical resource utilization For all secondary objectives, please refer to the protocol ;Primary end point(s): The primary efficacy endpoint is the RSV viral load area under the curve (AUC) from immediately prior to first dose of study drug through Day 5 derived from the RSV viral load as measured by a qRT-PCR assay in nasal swabs.;Timepoint(s) of evaluation of this end point: Through Day 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Virologic parameters derived from the RSV viral load as measured by a qRT-PCR assay in nasal swabs including: a) RSV viral load and change from baseline over time b) RSV viral load AUC from immediately prior to first dose of study drug (baseline) through Day 3, Day 8, and Day 14 c) time to undetectable RSV viral load d) proportion of subjects with undetectable RSV viral load at each timepoint throughout the study 2. Clinical course related endpoints - In hospitalized subjects and outpatients (these endpoints will be based on the Pediatric RSV Electronic Severity and Outcome Rating System [PRESORS] assessed throughout the study by parent(s)/caregiver(s) (parent[s]/caregiver[s] PRESORS) and by the investigator (clinician PRESORS) during scheduled visits): a) duration and severity of signs and symptoms of RSV disease b) change from baseline in parent(s)/caregiver(s) PRESORS scores (worsening or improvement) c) change from baseline in clinician PRESORS scores (worsening or improvement) d) time to resolution (ie, to none or mild) of RSV symptoms e) time to improvement based on general questions on overall health f) proportion of subjects with improvement or worsening of RSV disease based on general questions on overall health g) time to return to pre-RSV health as rated by the parent(s)/caregiver(s) In hospitalized subjects only: h) time to age-adjusted normal values for otherwise healthy and to pre-RSV infection status for subjects with (a) risk factor(s) for severe RSV disease, for heart rate, respiratory rate, and/or blood oxygen level (ie, without requirement of supplemental oxygen compared with pre-RSV infection status) i) time to discharge (from initial admission and from initiation of treatment) j) time to clinical stability, with clinical stability evaluated by the investigator (from initial admission and from initiation of treatment) 3. Safety and tolerability, as assessed by adverse events (AEs), clinical laboratory testing, electroc | — |
Countries
Argentina, Belgium, Brazil, Bulgaria, France, Germany, Hungary, Italy, Japan, Korea, Democratic People's Republic of, Malaysia, Mexico, Poland, Russian Federation, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed