A Clinical Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Relationships of Different Doses of JNJ-53718678 in Children =28 Days and =3 Years of Age With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus Infectio

Phase 1

• Conditions: Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus Infection; MedDRA version: 20.1Level: LLTClassification code 10066740Term: Acute respiratory tract infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 21.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-003642-93-DE
• Lead Sponsor: Janssen Sciences Ireland UC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-31
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 444

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 rapid-antigen-detection assay.
Note: If a subject had a positive similar RSV diagnostic test from another stud y 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/DEU-2:
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. Criterion modified per Amendment 5/DEU-2:
5.1 The time of onset of RSV symptoms to the anticipated time of randomization must be =3 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

Exclusion Criteria

Any potential subject who meets any of the following criteria will be excluded from participating in the study:
1. The subject is <3 months postnatal age at screening and was born prematurely (ie, <37 weeks and 0 days of gestation).
2. The subject weights <2.4 kilogram (kg) or =16.8 kg
3. The subject had major surgery within the 28 days prior to randomization or planned major surgery through the course of the study.
4. The subject has major congenital anomalies or known cytogenetic or metabolic disorders other than the ones allowed above.
Note: Isolated open ductus arteriosus and open foramen ovale are not exclusionary as these are not considered major anomalies. Subjects with congenital heart disease, cystic fibrosis, congenital diaphragmatic hernia, or Down Syndrome are allowed to participate.
5. The subject is considered by the investigator to be immunocompromised within the past 12 months, whether due to underlying medical condition (eg, malignancy or genetic disorder other than immunoglobulin A deficiency, or known human immunodeficiency virus [HIV] infection) or medical therapy (eg, immunomodulators other than corticosteroids for the treatment of comorbidities, chemotherapy, radiation, stem cell or solid organ transplant).
6. Criterion modified per Amendment 4:
6.1 The subject has other clinically significant abnormal ECG findings not consistent with the present risk factor for severe RSV disease (if applicable) in the study population, as judged by the investigator based on the machine read ECG results at screening.
7. Criterion modified per Amendment 4:
7.1 The subject has a QTcF interval >450 ms per the machine read (mean of triplicate) parameter result confirmed by repeat triplicate ECG recording during screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified