Clinical Burden of Disease of Norovirus Infections in German Hospitals: A Multicenter Retrospective Cohort Study

Clinical Burden of Disease of Norovirus Infections in German Hospitals: A Multicenter Retrospective Cohort Study - NORO-BURDEN

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00041008

Enrollment

1125

Registered

2026-07-15

Start date

2026-07-27

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

A08.1

Interventions

Group 1: This study is an exploratory retrospective, multicenter cohort study conducted at five tertiary care university hospitals in Germany. All patients with PCR-confirmed norovirus infection ident

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: PCR-confirmed norovirus infections

Exclusion criteria

Exclusion criteria: Asymptomatic carriers: Asymptomatic at the time of PCR diagnostic

Design outcomes

Primary

Measure	Time frame
The primary outcome is to quantify the clinical burden of disease among patients with laboratory-confirmed norovirus infection in tertiary care hospitals in Germany. The clinical burden is assessed by using a severity scale based on level of care and predefined clinical complications, categorized as follows: • Mild: outpatient management • Moderate: hospitalization without ICU admission and without organ complications • Severe: ICU admission and/or occurrence of organ complications • Fatal: in-hospital all-cause death As the patients’ severity may change throughout the observation period, the worst observed grade documented in the electronic medical records will be used for the analysis.	—

Measure

Time frame

The primary outcome is to quantify the clinical burden of disease among patients with laboratory-confirmed norovirus infection in tertiary care hospitals in Germany. The clinical burden is assessed by using a severity scale based on level of care and predefined clinical complications, categorized as follows: • Mild: outpatient management • Moderate: hospitalization without ICU admission and without organ complications • Severe: ICU admission and/or occurrence of organ complications • Fatal: in-hospital all-cause death As the patients’ severity may change throughout the observation period, the worst observed grade documented in the electronic medical records will be used for the analysis.

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Secondary

Measure	Time frame
The secondary objectives are to characterize the demographic and clinical features of patients with laboratory-confirmed norovirus infection and to describe and evaluate their clinical course and outcomes. Further, evidence of prolonged viral shedding or chronic norovirus infection will be assessed based on repeated laboratory-confirmed norovirus detection beyond the expected duration of acute infection. The following parameters will be captured from electronic medical records for descriptive analysis: age, sex, characterization of hospital (re)admission and discharge, clinical and laboratory parameters, date of pathogen detection, comorbidity burden (quantified using the Charlson Comorbidity Index), concomitant medication use, acquisition of infection, clinical burden, disease course, length of hospital stay, and all-cause readmission within 30 days and evidence of viral shedding/chronic infection.	—

Measure

Time frame

The secondary objectives are to characterize the demographic and clinical features of patients with laboratory-confirmed norovirus infection and to describe and evaluate their clinical course and outcomes. Further, evidence of prolonged viral shedding or chronic norovirus infection will be assessed based on repeated laboratory-confirmed norovirus detection beyond the expected duration of acute infection. The following parameters will be captured from electronic medical records for descriptive analysis: age, sex, characterization of hospital (re)admission and discharge, clinical and laboratory parameters, date of pathogen detection, comorbidity burden (quantified using the Charlson Comorbidity Index), concomitant medication use, acquisition of infection, clinical burden, disease course, length of hospital stay, and all-cause readmission within 30 days and evidence of viral shedding/chronic infection.

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Countries

Germany

Contacts

Public ContactMelanie Mayr

TUM Klinikum

melanie.mayr2@mri.tum.de+49 89 4140 5778

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026