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

NCT02133092 | Completed

• 2 other identifiers: CR103179ObserveRSV0001
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 4

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).

Conditions

Respiratory Syncytial Virus

Keywords

Respiratory syncytial virus; RSV; Lower respiratory tract infection; LRTI; Acute respiratory infection; Belgian children

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Change From Baseline in Clinical Symptoms Score (CSS)

  Day 1 (baseline) to Day 3

• Change From Baseline in Medical Support Score (MSS)

  Day 1 (baseline) to Day 3

Study Arms (1)

Patients with respiratory syncytial virus (RSV) infection

The RSV infection is laboratory confirmed

Other: No intervention

Interventions

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.

Patients with respiratory syncytial virus (RSV) infection

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients hospitalized with a laboratory confirmed Respiratory Syncytial Virus (RSV) lower respiratory tract infection.

You may qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (4)

Unknown Facility

Bruges, Belgium

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Lier, Belgium

Location

Unknown Facility

Ostend, Belgium

Location

Related Publications (1)

• 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.

  PMID: 35666728 DERIVED

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 7, 2014
• Study Start: December 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: October 17, 2016

Record last verified: 2016-10

Locations

BE (4)