Clinical trial NCT02133092: A Study in Belgian Children Hospitalized With Respiratory Syncytial Virus Related Acute Respiratory Infections
Official title: Prospective Study in Belgian Children Hospitalized With Respiratory Syncytial Virus Related Acute Respiratory Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Syncytial Virus
Keywords: Respiratory syncytial virus
RSV
Lower respiratory tract infection
LRTI
Acute respiratory infection
Belgian children
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2014-05-07
Enrollment: 62
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients hospitalized with a laboratory confirmed Respiratory Syncytial Virus (RSV) lower respiratory tract infection.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Respiratory Syncytial Virus (RSV) Viral Clearance
timeFrame: Day 1 to Day 3
Secondary outcomes:
measure: Change From Baseline in Clinical Symptoms Score (CSS)
timeFrame: Day 1 (baseline) to Day 3
measure: Change From Baseline in Medical Support Score (MSS)
timeFrame: Day 1 (baseline) to Day 3
Other outcomes:
Locations:
city: Brugge
country: Belgium
city: Leuven
country: Belgium
city: Lier
country: Belgium
city: Oostende
country: Belgium
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.