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Pediatric Airway Pathogen Incidence (PAPI) Study

Pediatric Airway Pathogen Incidence (PAPI) Study - PAPI Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00026155
Enrollment
1580
Registered
2021-10-19
Start date
2021-10-04
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B97.4 J12.1 J21.0 J20.5 J21.1 J21.8 J21.9

Interventions

Group 1: • Study arm "severe RSV LRTI" (hospitalized children) • The patients are recruited from the patient population of the participating clinics. • Information, examination of inclusion and exclus
Transmission of the findings to the respective study center (<24 h)
Entry of the findings by the local study team • Study arm "any RSV infection" (children treated on an outpatient basis) • The patients are recruited from the patient pool of the participating pediatr
the first two suitable patients in the afternoon). • Information, examination of inclusion and exclusion criteria and obtaining the declaration of consent from the local study coordinator • Collection

Sponsors

Medizinische Hochschule Hannover, Klinik für Pädiatrische Pneumologie, Allergologie und Neonatologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0 Months to 24 Months

Inclusion criteria

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

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)

Design outcomes

Secondary

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

Primary

MeasureTime frame
Detection of RSV in nasopharyngeal smear or aspirate using PCR diagnostics

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026