Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2026-01-01 @ 11:43 PM
Study NCT ID:
NCT02133092
Status:
COMPLETED
Last Update Posted:
2016-10-17
First Post:
2014-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study in Belgian Children Hospitalized With Respiratory Syncytial Virus Related Acute Respiratory Infections
Sponsor:
Janssen Research & Development, LLC
Organization:
Study Overview
Official Title:
Prospective Study in Belgian Children Hospitalized With Respiratory Syncytial Virus Related Acute Respiratory Infections
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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).
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ObserveRSV0001 | OTHER | Janssen Research & Development, LLC | View |