Hantavirus NephropathyHANTA-NENCT05415904
Hantavirus Nephropathy in North-Eastern France : Severity Risk Factors and Prognostic Tools
An observational study of Hantavirus Nephropathy and Hantavirus Infection, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Hantaviruses are emerging pathogens responsible for hemorrhagic fever with renal syndrome. Severity risks factors aren't consensual in litterature, mostly related to scandinavian cohorts. Read more about this study
- Who is it for?
- Ages 18 to 125 years
- Conditions the study is for
- Hantavirus Nephropathy, Hantavirus Infection
- What is being tested?
- HANTA-NE
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2022to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 125 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adults patient hospitalized for hantavirus infection during study time frame.
Who may be able to join
- hantavirus proven by serology infection
- age above 18 years
- Hospitalisation
Who cannot join
- age under 18 years
- fulfill opposition form
Trial locations and contacts
1 site in 1 country.
About this study
Hantaviruses are emerging pathogens responsible for hemorrhagic fever with renal syndrome. Severity risks factors aren't consensual in litterature, mostly related to scandinavian cohorts. A prognostic score was created to help patient's orientation in healthcare system but wasn't independantly validated (Hentzien, Emerging infectious diseases 2018).
This retrospective cohort of hantavirus infected hospitalized adults patients in the north-eastern quarter of France between 2013 and 2022 will specify the kidney damage during infection and risk factors for a severe form (defined par acute kidney injury KDIGO 3). The previous prognostic score performance will be evaluated in this cohort.
- Conditions
- Hantavirus Nephropathy, Hantavirus Infection
- Being tested
- HANTA-NE
- Keywords
- Acute kidney injury, Hantavirus infection, Hantavirus nephropathy
- Medical subject headings
- Hantavirus Infections, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HANTA-NEOther
Observational cohort study
| Study group | Role | What they receive |
|---|---|---|
| HANTA-NE | All adult patient hospitalized for hantavirus infection between 01/01/2013 and 31/12/2022 in North Eastern France Receives: Other: HANTA-NE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatinin level
Acute Kidney injury KDIGO 3
Measured: Through study completion, an average of 2 years
Hemorrhagic syndrome
Major bleeding requiring blood transfusion
Measured: Through study completion, an average of 2 years
Death
Death
Measured: Through study completion, an average of 2 years
Hospitalisation in intensive care unit
Hospitalisation in intensive care unit
Measured: Through study completion, an average of 2 years
Secondary outcomes (13)
Score performance to predict severity
Correlation between severity predicted by the score and bio-clinical severity during hospitalization.
Score composition :
Hematuria = 7 Visual disorders = 8 Leucocyte count > 10 x 10^9 cells/L = 9 Nephrotoxic drug exposure (NSAID, iodinated contrast media, diuretics, renin angiotensin aldosterone system inhibitors, aminoglycosides, glycopeptides) = 10 Thrombocytopenia < or = 90 000/mm3 = 11
Risk group according score scale 0-10 Low risk 11-19 intermediate risk 20-45 high risk
Measured: Through study completion, an average of 2 years
Hypotension
Lowest systolic blood presure during hospitalisation < 90mmHg
Measured: Through study completion, an average of 2 years
Proteinuria
Proteinuria during hospitalisation defined by proteinuria/creatininuria above 500 mg/g or equivalent
Measured: Through study completion,an average of 2 years
Urinary dipstick
Leucocyturia or hematuria
Measured: Through study completion, an average of 2 years
ALAT, ASAT
Liver cytolysis
Measured: Through study completion, an average of 2 years
calcium
hypocalcemia, hypercalcemia
Measured: Through study completion, an average of 2 years
phosphorus
hypophaspahtaemia, hyperphasphatemia
Measured: Through study completion, an average of 2 years
potassium
hypokaliemia, hyperkaliemia
Measured: Through study completion, an average of 2 years
sodium
blood sodium level disorders
Measured: Through study completion, an average of 2 years
bicarbonate blood level
metabolic acidosis, metabolic alcalosis
Measured: Through study completion, an average of 2 years
Heamoglobin
Anemia
Measured: Through study completion, an average of 2 years
platelets level
thrombocytemia
Measured: Through study completion, an average of 2 years
Urine output
Polyruria above 3 L/day
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start20 May 2022
- Primary completion30 Oct 2023
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hantavirus NephropathyStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CORBEL Alice, Central Hospital, Nancy, France
- Investigators
- Alice CORBEL, M.D., Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415904
- Sponsor's protocol ID
- 2022PI034
- Acronym
- HANTA-NE
- Status last verified
- Feb 2025
- First submitted
- 22 May 2022
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hantavirus Nephropathy in North-Eastern France : Severity Risk Factors and Prognostic Tools
- ClinicalTrials.gov ID
- NCT05415904
- Acronym / sponsor ID
- HANTA-NE / 2022PI034
- Conditions
- Hantavirus Nephropathy, Hantavirus Infection
- Keywords
- Acute kidney injury, Hantavirus infection, Hantavirus nephropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hantaviruses are emerging pathogens responsible for hemorrhagic fever with renal syndrome. Severity risks factors aren't consensual in litterature, mostly related to scandinavian cohorts. A prognostic score was created to help patient's orientation in healthcare system but wasn't independantly validated (Hentzien, Emerging infectious diseases 2018).
This retrospective cohort of hantavirus infected hospitalized adults patients in the north-eastern quarter of France between 2013 and 2022 will specify the kidney damage during infection and risk factors for a severe form (defined par acute kidney injury KDIGO 3). The previous prognostic score performance will be evaluated in this cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HANTA-NE | – | Other: HANTA-NEAll adult patient hospitalized for hantavirus infection between 01/01/2013 and 31/12/2022 in North Eastern France |
Who may qualify
- Ages
- 18 to 125 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults patient hospitalized for hantavirus infection during study time frame.
Key inclusion criteria (3 listed)
- hantavirus proven by serology infection
- age above 18 years
- Hospitalisation
Key exclusion criteria (2 listed)
- age under 18 years
- fulfill opposition form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HANTA-NEObservational cohort study | Other | HANTA-NE |
Primary outcome
Creatinin level
Time frame: Through study completion, an average of 2 years
Acute Kidney injury KDIGO 3
Hemorrhagic syndrome
Time frame: Through study completion, an average of 2 years
Major bleeding requiring blood transfusion
Death
Time frame: Through study completion, an average of 2 years
Death
Hospitalisation in intensive care unit
Time frame: Through study completion, an average of 2 years
Hospitalisation in intensive care unit
13 secondary outcomes
Score performance to predict severity
Time frame: Through study completion, an average of 2 years
Hypotension
Time frame: Through study completion, an average of 2 years
Proteinuria
Time frame: Through study completion,an average of 2 years
Urinary dipstick
Time frame: Through study completion, an average of 2 years
ALAT, ASAT
Time frame: Through study completion, an average of 2 years
calcium
Time frame: Through study completion, an average of 2 years
phosphorus
Time frame: Through study completion, an average of 2 years
potassium
Time frame: Through study completion, an average of 2 years
sodium
Time frame: Through study completion, an average of 2 years
bicarbonate blood level
Time frame: Through study completion, an average of 2 years
Heamoglobin
Time frame: Through study completion, an average of 2 years
platelets level
Time frame: Through study completion, an average of 2 years
Urine output
Time frame: Through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice CORBEL, M.D. principal investigator
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hantavirus Nephropathy and Hantavirus Infection, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creatinin level (time frame: Through study completion, an average of 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.