Pediatric Airway Pathogen Incidence (PAPI) Study

Recruiting

• Conditions: B97.4; J12.1; J21.0; J20.5; J21.1; J21.8; J21.9; Respiratory syncytial virus as the cause of diseases classified to other chapters; Respiratory syncytial virus pneumonia; Acute bronchiolitis due to respiratory syncytial virus

• Registration Number: DRKS00026155
• Lead Sponsor: Medizinische Hochschule Hannover, Klinik für Pädiatrische Pneumologie, Allergologie und Neonatologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1580

Inclusion Criteria

Study arm severe RSV LRTI (hospitalized children)
• Children aged 0-24 months
• Parental consent to the study
• Episode requiring hospitalization
• Existence of the case definition (at least one criterion from group A and B)
Inclusion criteria Group A
-Fever = 38.5 ° C (rectal) or 38.0 ° C (auricular, axillary, sublingual)
-Cough
-Signs of rhinitis (runny nose, blocked nasal breathing)
-Signs of pharyngitis (difficulty swallowing, sore throat)
Inclusion criteria group B
-Giemen (auscultation)
-rattling noises
-Tachy / dyspnea
-Hypoxemia

Study arm any RSV infection (children treated on an outpatient basis)
• Children aged 0-24 months
• Parental consent to the study
• The case definition is available (at least one criterion from group A or B)
Inclusion criteria Group A
-Fever = 38.5 ° C (rectal) or 38.0 ° C (auricular, axillary, sublingual)
-Cough
-Signs of rhinitis (runny nose, blocked nasal breathing)
-Signs of pharyngitis (difficulty swallowing, sore throat)
Inclusion criteria group B
-Giemen (auscultation)
-rattle noises
-Tachy / dyspnea
-Hypoxemia

Exclusion Criteria

Study arm severe RSV LRTI (hospitalized children)
• Child is hospitalized for> 72 hours
• Participation in the study at an earlier point in time (winter half-year / current season)

Study arm any RSV infection (children treated on an outpatient basis)
• Participation in the study within the last 28 days (current season)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of RSV in nasopharyngeal smear or aspirate using PCR diagnostics

Secondary Outcome Measures

Name	Time	Method
Detection of other respiratory pathogens (PCR) in nasopharyngeal smear or aspirate; Clinical course of RSV infection; Socio-economic costs of RSV infections