Acute Hepatitis, Chronic Hepatitis, Hepatitis, Liver Disease Chronic, Liver Diseases
Conditions
Keywords
Orthohepevirus C, Hepatitis, Liver Diseases
Brief summary
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
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
Interventions
None listed
Sponsors
Maimónides Biomedical Research Institute of Córdoba
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Existence of Ortho-C infection | 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. |
Countries
Spain
Contacts
Primary ContactANTONIO RIVERO ROMÁN
Outcome results
None listed