Evaluation of Orthohepevirus C Infection as an Emerging Cause of Zoonotic Origin Disease

September 29, 2021 updated by: Maimónides Biomedical Research Institute of Córdoba
The main objective of this study is to evaluate the prevalence and the clinical impact of Orthohepevirus C infection in different human populations, and to determine its zoonotic origin comparing the sequences obtained in both human and animal populations. This is an ambispective study where Orthohepevirus C infection will be evaluated in four high risk human population: i) patients with acute hepatitis, ii) patients with positive IgM antibody against Hepatitis E virus infection with undetectable viral load, iii) HIV infected individuals, and iv) solid organ transplant recipients. Furthermore, we will analyze three animal populations: i) suburban rodents, ii) domestic rodents, iii) wild carnivores. Viral sequences identified in both human and animal populations will be compared to evaluate the zoonotic origin of the infections.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

To carry out the project a database will be created in electronic format, where the study team will integrate epidemiological, clinical and laboratory tests data of patients. Data will be anonymous and coded by a data manager.

Primary objective is to assess the prevalence of Ortho-C infection in patients with acute hepatitis of no identified origin

Secondary objectives are:

  1. To evaluate the prevalence and risk factors of Ortho-C infection in patients with solid organ transplant.
  2. To evaluate the prevalence and risk factors of Ortho-C infection in patients with HIV infection.
  3. To assess the presence of Ortho-C infection in patients with the presence of antibodies (IgM) against HEV and absence of HEV-RNA
  4. To evaluate the prevalence of infection by Ortho-C in wild and periurban rodents.
  5. To evaluate the prevalence of infection by Ortho-C in domestic rodents and mustelids.
  6. To evaluate the prevalence of infection by Ortho-C in wild carnivores
  7. To molecularly characterize and evaluate the degree of homology of Ortho-C viral sequences found in humans and animals

Study Type

Observational

Enrollment (Anticipated)

3257

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Ciudad Real, Spain
        • Instituto de Investigacion En Recursos Cinegeticos (Irec)
        • Contact:
          • JOSE FRANCISCO RUIZ FONS
        • Principal Investigator:
          • JOSE FRANCISCO RUIZ FONS
        • Sub-Investigator:
          • RAUL CUADRADO MATIAS
      • Córdoba, Spain, 14004
        • Facultad de Veterinaria de Cordoba
        • Contact:
          • DAVID CANO TERRIZA
        • Principal Investigator:
          • DAVID CANO TERRIZA
      • Córdoba, Spain, 14004
        • Fundacion Investigacion Biomedica de Cordoba (Fibico)
        • Contact:
          • ANTONIO RIVERO ROMAN
        • Sub-Investigator:
          • ANGELA CAMACHO ESPEJO
        • Principal Investigator:
          • Antonio Rivero Román
        • Sub-Investigator:
          • ISABEL MARIA MACHUCA SANCHEZ
        • Sub-Investigator:
          • ANA BELEN PEREZ JIMENEZ
      • Córdoba, Spain, 14004
        • Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)
      • Granada, Spain
        • Hospital Universitario San Cecilio
        • Contact:
          • ANA FUENTES LOPEZ
        • Principal Investigator:
          • ANA FUENTES LOPEZ
      • Madrid, Spain
        • Clinica Universidad de Navarra
        • Contact:
          • GABRIEL REINA GONZALEZ
        • Principal Investigator:
          • GABRIEL REINA GONZALEZ
      • Málaga, Spain
        • Complejo Hospitalario de Especialidades Virgen de la Victoria
        • Contact:
          • ISABEL VICIANA RAMOS
        • Principal Investigator:
          • ISABEL VICIANA RAMOS
    • Cádiz
      • Jerez De La Frontera, Cádiz, Spain
        • Hospital De Jerez De La Frontera
        • Contact:
          • JUAN CARLOS ALADOS ARBOLEDAS
        • Principal Investigator:
          • JUAN CARLOS ALADOS ARBOLEDAS
      • Puerto Real, Cádiz, Spain, 11510
        • Hospital de Puerto Real
        • Contact:
          • CAROLINA FREYRE CARRILLO
        • Principal Investigator:
          • CAROLINA FREYRE CARRILLO
    • Galicia
      • Santiago De Compostela, Galicia, Spain
        • Fundacion Instituto de Investigacion Sanitaria de Santiago de Compostela
        • Contact:
          • ANTONIO AGUILERA GUIRAO
        • Principal Investigator:
          • ANTONIO AGUILERA GUIRAO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Depending on the cohort. Please see "Group and Interventions" section to learn about the study population in each cohort.

Description

1. HAOD cohort (Cohort of patients with acute hepatitis of unknown origin)

  • Patients older than 18 years with acute hepatitis of unknown origin (HAOD)

    2. OrthoC-Tx cohort (HEV Screening Cohort in Transplant Patients):

  • Kidney or liver transplant subjects

    3. Ortho-CoRIS Cohort (derived from the AIDS Research Network Cohort (CoRIS))

  • HIV-infected patients being monitored by the Spanish AIDS Research Network (RIS)

    4. TrazHE Cohort (Traceability cohort of Hepatitis E infections)

  • Patients with the presence of antibodies (IgM) against HEV and absence of HEV-RNA

    5. Ortho-C-Rodent Collection:

  • Wild and peri-urban rodents (rats) from different areas of Spain

    6. Ortho-C-Domestic Rodent Collection:

  • Domestic rodents and mustelids under follow-up in veterinary clinics of different Spanish municipalities.

    7. Ortho-C-Carnivore Collection:

  • Wild carnivores that eat rodents collected by the research team since 2020 in 4 autonomous communities (Extremadura, Andalusia, Murcia and Castilla la Mancha)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
HAOD Cohort

This cohort includes patients with acute hepatitis of unknown origin, meaning its origin could not be determined after screening of (at least) HAV, HAB, HAC, HAE, Epstein-Barr virus and cytomegalovirus. Patients will be recruited in 17 centres nationwide.

The research group will receive a 1mL plasma / serum sample from each patient to study the presence of Ortho-C infection
OrthoC-Tx Cohort
This cohort includes liver or kidney transplant patients under follow-up. The research group will receive a 1mL plasma / serum sample every year from each patient to study the presence of Ortho-C infection
Ortho-CoRIS Cohort

This cohort includes VIH positive patients who are in follow-up by the Spanish Network of AIDS Research.

The research group will receive a plasma / serum sample every year from each patient to study the presence of Ortho-C infection.
TrazHE Cohort

This cohort includes patients whose clinical picture is compatible with HAE infection.

The presence of Ortho-C infection will be studied in patients with positive IgM for HAE and absence of RNA-HAE.
Ortho-C-Rodent Cohort
This cohort includes wild rats. Feces and liver samples will be taken in order to determine the prevalence of Ortho-C in wild rats (Ortho-C's main reservoir).
Ortho-C-Domestic Rodent Cohort
This cohort includes domestic rats and mustelids. Feces and liver samples will be taken in order to determine the prevalence of Ortho-C in domestic rats and mustelids.
Ortho-C-Carnivore Cohort

This cohort includes 236 wild carnivores that feed off rodents. Carnivores' cause of death is they were run over.

Feces, liver and serum samples will be taken to study the transmission of Ortho-C.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Existence of Ortho-C infection
Time Frame: Yearly, up to three years.

The presence of Ortho-C infection is defined by:

  • HAOD, TrazHE, OrthoC-Tx and Ortho-CoRIS cohorts: presence of RNA-OrthoC in blood.
  • Ortho-C-Rodent and Ortho-C-Carnivore cohorts: presence of RNA-OrthoC in serum, feces and/or liver tissue
  • Ortho-C-Domestic-Rodent cohort: presence of RNA-OrthoC in feces.
Yearly, up to three years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Investigators

  • Principal Investigator: ANTONIO RIVERO ROMÁN, Hospital Universitario Reina Sofia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2022

Primary Completion (ANTICIPATED)

October 1, 2024

Study Completion (ANTICIPATED)

December 1, 2024

Study Registration Dates

First Submitted

September 17, 2021

First Submitted That Met QC Criteria

September 29, 2021

First Posted (ACTUAL)

September 30, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 30, 2021

Last Update Submitted That Met QC Criteria

September 29, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI21/00793

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Sharing the results of this study after they are made public.

IPD Sharing Time Frame

After study results are published.

IPD Sharing Access Criteria

Send access request to principal investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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