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| ID | Type | Description | Link |
|---|---|---|---|
| ObserveRSV0001 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of the study is to assess viral kinetics and clinical symptoms kinetics in pediatric patients hospitalized with Respiratory Syncytial Virus (RSV) confirmed lower respiratory tract infection (LRTI).
This is an exploratory prospective study (a study in which the patients are identified and then followed forward in time for the outcome of the study). The study will consist of two phases: a screening phase (Day 1) and an assessment phase (Day 2 to Day 7). During screening phase, in pediatric patients hospitalized with LRTI and from whom the informed consent form was obtained, diagnosis of RSV infection will be performed within 24h from the hospital admission, using a SOFIA POC test on nasal specimens. During the assessment phase the collection of nasal specimens will be done daily for a maximum of 6 days (Day 2 to Day 7 of hospitalization) or until patient discharge from hospital. Approximately 50 patients will be enrolled in this study. The total duration of the study for each participant will be approximately 7 days. The study duration will extend during 1-3 RSV epidemic seasons, or until the targeted number of 50 RSV hospitalized children have completed the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with respiratory syncytial virus (RSV) infection | The RSV infection is laboratory confirmed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | This is an observational study. The children hospitalized with lower respiratory tract infection (LRTI) with a laboratory confirmed RSV infection will be monitored for maximum 7 days or until hospital discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Respiratory Syncytial Virus (RSV) Viral Clearance | RSV viral clearance, defined as the change in log viral load (VL) from Day 1 to Day 3, where the VL is measured in nasal specimens with quantitative reverse transcript poly cycle reaction (qRT-PCR). | Day 1 to Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Clinical Symptoms Score (CSS) | The severity of the RSV disease will be assessed using CSS. CSS will be computed based on clinical parameters (O2 saturation, heart rate, respiratory rate) and lung auscultation examination. CSS score ranges from 0 (best) to 15 (worst). Higher scores indicate worsening. | Day 1 (baseline) to Day 3 |
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Inclusion Criteria:
Exclusion Criteria:
- Participant does not fulfill the inclusion criteria
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Pediatric patients hospitalized with a laboratory confirmed Respiratory Syncytial Virus (RSV) lower respiratory tract infection.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bruges | Belgium | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35666728 | Derived | Proesmans M, Rector A, Keyaerts E, Vandendijck Y, Vermeulen F, Sauer K, Reynders M, Verschelde A, Laffut W, Garmyn K, Fleischhackl R, Bollekens J, Ispas G. Risk factors for disease severity and increased medical resource utilization in respiratory syncytial virus (+) hospitalized children: A descriptive study conducted in four Belgian hospitals. PLoS One. 2022 Jun 6;17(6):e0268532. doi: 10.1371/journal.pone.0268532. eCollection 2022. |
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| Change From Baseline in Medical Support Score (MSS) | The severity of the RSV disease will be assessed using MSS. MSS will take into account the use of supplementary oxygen, the request for mechanical ventilation, intensive care unit admission and the length of hospitalization. The MSS score ranges from 0 (best) to 5 (worst). Higher scores indicate worsening. | Day 1 (baseline) to Day 3 |
| Leuven |
| Belgium |
| Lier | Belgium |
| Ostend | Belgium |