Respiratory syncytial virus infection respiratory tract infection
Conditions
Interventions
Subjects will be dosed orally once daily (qd) or twice daily (bid), depending
on the assigned dose regimen, during 7 days (Day 1-Day 7). Dosing should occur
approximately at the same time(s) each da
Sponsors
Janssen Science Ireland UC
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: 1. Each subject*s legally acceptable representative (ie, parent(s)/legal guardian/caregiver) must sign an 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 (see Section 4.3) and study procedures. 2. Subject has presented at the hospital for suspected RSV infection within 72 hours prior to screening completion (ie, randomization). 3. Subject has been hospitalized for this suspected RSV infection. 4. Subject is a boy or a girl, who is >1 month to =37 weeks and 0 days). 7. With the exception of the RSV-related illness, subject is otherwise in good health without any significant medical illness on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, skin examination, medical history, vital signs, ECG, and the results of blood biochemistry, blood coagulation, and hematology tests performed at Screening. If there are abnormalities, the subject may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the subject*s source documents and initiated by the Investigator. Note: Procedures that are standard of care and performed within 72 hours prior to screening completion (ie, randomization) may be used in determining study eligibility.
Exclusion criteria
Exclusion criteria: 1. Subject is upon current admission initially hospitalized in the ICU and/or in need of invasive endotracheal mechanical ventilation. 2. Subject has a history of any illness or a concurrent illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit or confound the protocol-specified assessments. This may include, but is not limited to, bacteremia, gross abnormalities, organ dysfunction, or severe comorbidity. Note: The use of intravenous fluids is not exclusionary as long as the Investigator believes the patient*s gastrointestinal tract still functions properly (i.e., is able to absorb drugs or nutrition). 3. Subjects who had major surgery within the 28 days prior to randomization or planned major surgery through the course of the study. 4. Subject has major congenital anomalies (eg, AV shunt) or known cytogenetic disorders (eg, Down*s syndrome). Note: Open ductus arteriosus and open foramen ovale are not exclusionary as not considered major anomalies. 5. Subject has known or suspected immunodeficiency, such as known human immunodeficiency virus (HIV) infection. 6. Subject has known or suspected hepatitis B or C infection. 7. Subject has known allergies, hypersensitivity, or intolerance to JNJ-53718678 or its excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are: • the pharmacokinetic parameters of JNJ-53718678; • the safety/tolerability data including, but not limited to, AEs, physical examinations, vital signs, ECGs, and clinical laboratory results. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are: • RSV viral load as measured by qRT-PCR in nasal swabs will be used to determine the following; -AUC of RSV viral load over time; -viral load over time, peak viral load, and time to peak viral load; -proportion of subjects reaching undetectability of virus between first administration of study drug and Day 28. •RSV clinical course endpoints including: -Length of hospital stay from admission to discharge; -Need and duration of supplemental oxygen requirement (type and duration [h]); -Need and duration of ICU stay; -Need and duration of non-invasive ventilator support (eg, continuous positive airway pressure [CPAP]); -Number of hours until saturation >92% on room air; -Need and duration of endotracheal mechanical ventilation; -Evolution of respiratory rate, SpO2, and body temperature; -Evolution of RSV symptoms as assessed by the clinician COA; -Amount of food intake, hydration, and feeding by IV. Exploratory endpoints are: • Evolution of RSV symptoms as assessed by the parent/caregiver COA; • Relationship between various pharmacokinetic parameters and RSV clinical course and antiviral endpoints; • Impact of viral genotype on antiviral response; • Sequence analysis of the RSV F-gene before treatment (at baseline), during treatment, and post-treatment, as applicable; • Presence of co-infections at Screening and detected retrospectively. The methodology that will be used to detect co-infections will be described in a separate laboratory manual; • Time to clinical stability. | — |
Countries
Netherlands
Outcome results
None listed