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Hantavirus Registry Gathers Knowledge on Epidemiology, Clinical Course, Prognostic Factors and Molecular Characteristics for Hantavirus Infections and Their Complications (HantaReg) (HantaReg)

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ClinicalTrials.gov Identifier: NCT04323904
Recruitment Status : Recruiting
First Posted : March 27, 2020
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
Volker Burst, University of Cologne

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.


Condition or disease Intervention/treatment
Hantavirus Infections Hemorrhagic Fever With Renal Syndrome Nephropathia Epidemica Hantavirus Cardiopulmonary Syndrome Other: Retrospective data collection

Detailed Description:

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. HRFS caused by Hantaan virus, Amur virus and Dobrava-Belgrade virus lead to severe clinical course of the disease, with mortality ranging from 10-15%, whereas Seoul virus and Puumula virus result in mild to moderate from of disease with a mortality below <1%, also referred to as nephropathia epidemica. New World hantaviruses cause HCPS leading to acute respiratory distress syndrome (ARDS) and heart rhythm disorders with attributable mortality ranging high from 30-50%. However, there are hints that HRFS and HCPS overlap with a combined clinical course with cardiopulmonary, renal and hemorrhagic symptoms being present simultaneously. Due to climate changes and globalization, outbreak situations of hantavirus disease throughout Europe are increasing and there are worrisome trends regarding changing of species distributions in Europe.

At present, there is no specific therapy available for hantavirus disease. Treatment approaches are primarily supportive with admission of patients to the intensive care unit (ICU) and maintenance of fluid and electrolyte balance. Patients with severe renal insufficiency and fluid retention, pulmonary edema or hyperkalemia may require dialysis. In case of extensive thrombocytopenia and present bleeding, platelet transfusion may be needed. In HCPS, treatment approaches consist of the supplementation of oxygen, mechanical ventilation and in case of extended acute respiratory distress syndrome (ARDS) extracorporeal membrane oxygenation (ECMO).

Due to increasingly frequent outbreak situations and globally chances in species distributions, a worldwide surveillance in epidemiology and species attribution is needed. 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.

The objective of the Hantavirus Registry - HantaReg is to overcome the lack of knowledge on epidemiology, clinical course and prognostic factors for hantavirus infections and their complications, as well as to serve as a platform for future studies and outbreak situations.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Hantavirus Registry - HantaReg
Actual Study Start Date : March 4, 2020
Estimated Primary Completion Date : March 2030
Estimated Study Completion Date : December 2030


Group/Cohort Intervention/treatment
Hantavirus Group
Patients with cultural, serological, molecular evidence of hantavirus infection
Other: Retrospective data collection
Retrospective data collection from patients with hantavirus infection and matching control group patients.

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




Primary Outcome Measures :
  1. Incidence [ Time Frame: up to 100 weeks ]
    To describe the global incidence of hantavirus infections

  2. Mortality [ Time Frame: up to 100 weeks ]
    To describe the global mortality due to hantavirus infections


Secondary Outcome Measures :
  1. Complications [ Time Frame: at 90 days from diagnosis ]
    To describe complications of hantavirus infections

  2. Therapeutic approaches [ Time Frame: at 90 days from diagnosis ]
    To describe therapeutic approaches of hantavirus infections

  3. First-line and salvage treatment approaches [ Time Frame: at 90 days from diagnosis ]
    To describe first-line and salvage treatment approaches and their efficacy and impact on patients' outcome

  4. Recommendations for diagnosis and treatment [ Time Frame: at 90 days from diagnosis ]
    To develop clinical screening and diagnostic approaches



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323904


Contacts
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Contact: Felix Köhler, MD +4922147897222 felix.koehler@uk-koeln.de
Contact: Felix Köhler, MD felix.koehler@uk-koeln.de

Locations
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Germany
University Hospital of Cologne Recruiting
Cologne, North-Rhine Westfalia, Germany, 50937
Contact: Felix Köhler, MD       felix.koehler@uk-koeln.de   
Contact: Felix Köhler, MD       kidneyinfection@uk-koeln.de   
Sponsors and Collaborators
University of Cologne
Investigators
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Principal Investigator: Volker Burst, MD University Hospital of Cologne
Additional Information:
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Responsible Party: Volker Burst, Principal Investigator, University of Cologne
ClinicalTrials.gov Identifier: NCT04323904    
Other Study ID Numbers: HantaReg
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Hemorrhagic Fevers, Viral
Hantavirus Pulmonary Syndrome
Hantavirus Infections
Hemorrhagic Fever with Renal Syndrome
Balkan Nephropathy
Syndrome
Disease
Pathologic Processes
RNA Virus Infections
Virus Diseases
Bunyaviridae Infections
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Nephritis, Interstitial
Nephritis
Kidney Diseases
Urologic Diseases