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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02133092
Other study ID # CR103179
Secondary ID ObserveRSV0001
Status Completed
Phase Phase 0
First received May 6, 2014
Last updated October 14, 2016
Start date December 2013
Est. completion date January 2015

Study information

Verified date October 2016
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority Belgium: Commissie Medische Ethiek van de Universitaire Ziekenhuizen K.U.Leuven
Study type Observational

Clinical Trial 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).


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, in pediatric patients hospitalized with LRTI and from whom the informed consent form was obtained, diagnosis of RSV infection will be performed within 24h from the hospital admission, using a SOFIA POC test 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 patient discharge from hospital. Approximately 50 patients will be enrolled in this study. The total duration of the study for each participant will be approximately 7 days. The study duration will extend during 1-3 RSV epidemic seasons, or until the targeted number of 50 RSV hospitalized children have completed the study.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group N/A to 5 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Participant does not fulfill the inclusion criteria

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Intervention

Other:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 No
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