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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3257 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-12-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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Hepatitis Liver Diseases Acute Hepatitis Chronic Hepatitis Liver Disease Chronic

Keywords

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Orthohepevirus C Hepatitis Liver Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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