Hantavirus Registry - HantaReg

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of Cologne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

None

Trial 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).

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • Retrospective data collection

    Other intervention

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Hantavirus Group1 intervention
Group B: Control group1 intervention

Trial outcomes

Primary outcomes

1

Incidence

To describe the global incidence of hantavirus infections

Time frame
up to 100 weeks
2

Mortality

To describe the global mortality due to hantavirus infections

Time frame
up to 100 weeks

Secondary outcomes

1

Complications

To describe complications of hantavirus infections

Time frame
at 90 days from diagnosis
2

Therapeutic approaches

To describe therapeutic approaches of hantavirus infections

Time frame
at 90 days from diagnosis
3

First-line and salvage treatment approaches

To describe first-line and salvage treatment approaches and their efficacy and impact on patients' outcome

Time frame
at 90 days from diagnosis
4

Recommendations for diagnosis and treatment

To develop clinical screening and diagnostic approaches

Time frame
at 90 days from diagnosis

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.