A Study in Japanese Children Hospitalized With Respiratory Syncytial Virus Related Lower Respiratory Tract Infections

NCT02132923 | Completed

• 2 other identifiers: CR103420ObserveRSV0002
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess viral kinetics and clinical symptoms kinetics of Respiratory Syncytial Virus (RSV) in pediatric patients hospitalized with RSV confirmed lower respiratory tract infection (LRTI).

Conditions

Respiratory Syncytial Virus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Respiratory Syncytial Viral Load (rate of 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 (baseline) 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

Biological: No intervention

Interventions

No intervention BIOLOGICAL

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 onsent 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)
• Patient 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
• Patient is RSV positive based on a rapid point of care (POC) detection method. The diagnosis of RSV infection will follow the standard medical procedure in the hospital unit

Sponsors & Collaborators

• Janssen R&D Ireland: lead

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

Study Officials

• Janssen R&D Ireland Clinical Trial

  Janssen R&D Ireland

  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 5, 2015

Record last verified: 2015-10

Locations

JP (1)