NCT02132923

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 49 (actual)
• Sponsor: Janssen R&D Ireland · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Respiratory Syncytial Virus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2014-05-07
• Last updated: 2015-10-05

Locations

1 site across 1 country: Japan