A Study in Belgian Children Hospitalized With Respiratory Syncytial Virus Related Acute Respiratory Infections

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Respiratory Syncytial Virus

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT02133092

CR103179

ObserveRSV0001 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 62 patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Legal representative has provided Ethics Committee approved written informed consent prior to any study-related procedure(s) being performed and is willing to allow the participation of child to the study for 7 consecutive days or until hospital discharge (whatever comes first)
• Participant hospitalized with lower respiratory tract infection (LRTI) during respiratory syncytial virus (RSV) epidemics, within 24h of hospitalization. The diagnosis of LRTI will follow the standard medical procedure in the hospital unit
• Onset of acute respiratory symptoms was less than or equal to 5 days ago
• For the participation in the assessment phase the hospitalized participant will have an RSV confirmed infection based on SOFIA RSV point of care (POC) test

Exclusion criteria

• Participant does not fulfill the inclusion criteria

Trial design

62 participants in 1 patient group

Patients with respiratory syncytial virus (RSV) infection

Description:

The RSV infection is laboratory confirmed

Treatment:

Other: No intervention