Hantavirus Registry - HantaReg

NCT04323904 | Recruiting

• 1 other identifier: HantaReg
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Hantavirus disease are zoonotic infections and remain a clinical challenge with globally increasing incidence and multiple serious outbreak situations in Europe within the last years. Hantavirus disease encompasses two clinical syndromes, hemorrhagic fever with renal syndrome (HFRS) and hantavirus cardiopulmonary syndrome (HCPS) caused by Old World and New World hantaviruses, respectively. Depending on the causative Old World hantavirus species, clinical course of HFRS can vary from mild to moderate to severe. At present, there is no specific therapy available for hantavirus disease. As the clinical course of hantavirus disease is dependent on the causing viral pathogen and as there worrisome hints that clinical course HFRS and HCPS overlap, further studies with regard to the disease course are mandatory. Furthermore, the examination of attributable mortality and costs of hantavirus disease will need to be studied on a multinational basis and therefore HantaReg will particularly use a matched case control design.

Conditions

Hemorrhagic Fever With Renal Syndrome; Nephropathia Epidemica; Hantavirus Cardiopulmonary Syndrome; Hantavirus Infections

Outcome Measures

Primary Outcomes (2)

• Incidence

  To describe the global incidence of hantavirus infections

  up to 100 weeks

• Mortality

  To describe the global mortality due to hantavirus infections

  up to 100 weeks

Secondary Outcomes (4)

• Complications

  at 90 days from diagnosis

• Therapeutic approaches

  at 90 days from diagnosis

• First-line and salvage treatment approaches

  at 90 days from diagnosis

• Recommendations for diagnosis and treatment

  at 90 days from diagnosis

Study Arms (2)

Hantavirus Group

Patients with cultural, serological, molecular evidence of hantavirus infection

Other: Retrospective data collection

Control group

Controls will be included at the same hospitals that conduced cases based on matching of demographics, underlying diseases and duration of hospitalization (i.e. one control per case, both in the same hospital)

Other: Retrospective data collection

Interventions

Retrospective data collection OTHER

Retrospective data collection from patients with hantavirus infection and matching control group patients.

Control group; Hantavirus Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with serological or molecular evidence of hantavirus infection and clinical evidence of nephropathia epidemica or hemorrhagic fever with renal syndrome (HFRS), or serological or molecular evidence of hantavirus infection and clinical evidence of hantavirus cardiopulmonary syndrome (HCPS). Particularly, controls will be identified retrospectively at the same hospitals that based on matching of demographics, underlying diseases and duration of hospitalization (i.e. one control per case, both in the same hospital).

You may qualify if:

• Serological or molecular evidence of hantavirus infection and clinical evidence of nephropathia epidemica or hemorrhagic fever with renal syndrome (HFRS)
• Serological or molecular evidence of hantavirus infection and clinical evidence of hantavirus cardiopulmonary syndrome (HCPS)

You may not qualify if:

• \- Serological or molecular evidence of hantavirus infection without clinical signs of nephropathia epidemica, HFRS or HCPS

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University Hospital of Cologne

Cologne, North-Rhine Westfalia, 50937, Germany

RECRUITING

Related Links

• Related information

MeSH Terms

Conditions

Hantavirus Infections; Hemorrhagic Fever with Renal Syndrome

Condition Hierarchy (Ancestors)

Bunyaviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Hemorrhagic Fevers, Viral

Study Officials

• Volker Burst, MD

  University Hospital of Cologne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Felix Köhler, MD

CONTACT

+4922147897222; felix.koehler@uk-koeln.de

Felix Köhler, MD

CONTACT

felix.koehler@uk-koeln.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 27, 2020
• Study Start: March 4, 2020
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)