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

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

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).

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus
• Intervention / Treatment: Biological: No intervention

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, pediatric patients consecutively hospitalized with RSV-related infection will be enrolled in the study within 24 hours of admission if symptomatic for maximum 5 days before the hospital admission and if the informed consent form (ICF) was obtained. The diagnosis of RSV infection will follow using a standard of care (SOC) rapid point point of care (POC) detection method available in the hospital unit 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 patients will be discharged from hospital. Approximately 50 patients will be enrolled in this study. The total duration of the study for each patient will be approximately 7 days. The study duration will extend until the targeted number of 50 RSV hospitalized children have completed the study.

• Study Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

- Patient does not fulfill the inclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with respiratory syncytial virus (RSV) infection; The RSV infection is laboratory confirmed	Biological: No intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Clinical Symptoms Score (CSS)	The severity of the RSV disease will be assessed using CSS. CSS will be computed based on clinical parameters (O2 saturation, heart rate, respiratory rate) and lung auscultation examination. CSS score ranges from 0 (best) to 15 (worst). Higher scores indicate worsening.	Day 1 (baseline) to Day 3
Change From Baseline in Medical Support Score (MSS)	The severity of the RSV disease will be assessed using MSS. MSS will take into account the use of supplementary oxygen, the request for mechanical ventilation, intensive care unit admission and the length of hospitalization. The MSS score ranges from 0 (best) to 5 (worst). Higher scores indicate worsening.	Day 1 (baseline) to Day 3

Collaborators and Investigators

• Sponsor: Janssen R&D Ireland

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: May 6, 2014
• First Submitted That Met QC Criteria: May 6, 2014
• First Posted (Estimate): May 7, 2014

Study Record Updates

• Last Update Posted (Estimate): October 5, 2015
• Last Update Submitted That Met QC Criteria: October 2, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Respiratory syncytial virus; RSV; LRTI; Acute respiratory infection; Lower respiratory tract infection; Japanese children
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Infections; Respiratory Tract Infections
• Other Study ID Numbers: CR103420; ObserveRSV0002 (Other Identifier: Janssen R&D Ireland)