Clinical trial NCT02132923: A Study in Japanese Children Hospitalized With Respiratory Syncytial Virus Related Lower Respiratory Tract Infections
Official title: Prospective Study in Japanese Children Hospitalized With Respiratory Syncytial Virus Related Lower Respiratory Tract Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Syncytial Virus
Keywords: Respiratory syncytial virus
RSV
Lower respiratory tract infection
LRTI
Acute respiratory infection
Japanese children
Lead sponsor: Janssen R&D Ireland
Sponsor class: INDUSTRY
First posted: 2014-05-07
Enrollment: 49
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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Respiratory Syncytial Viral Load (rate of viral clearance)
timeFrame: Day 1 (baseline) 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: Tokyo
country: Japan
Study officials:
affiliation: Janssen R&D Ireland
name: Janssen R&D Ireland Clinical Trial
role: STUDY_DIRECTOR
References: