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

Sponsor

Maimónides Biomedical Research Institute of Córdoba (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05062967

Collaborator

(none)

3,257

Enrollment

Locations

Anticipated Duration (Months)

325.7

Patients Per Site

9.3

Patients Per Site Per Month

Study Details

Study Description

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

solid organ transplant recipients. Furthermore, we will analyze three animal populations:
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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis Liver Diseases Acute Hepatitis Chronic Hepatitis Liver Disease Chronic

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:

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

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

3257 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

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

Kidney or liver transplant subjects

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

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

TrazHE Cohort (Traceability cohort of Hepatitis E infections)

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

Ortho-C-Rodent Collection:

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

Ortho-C-Domestic Rodent Collection:

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

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital de Jerez de La Frontera	Jerez De La Frontera	Cádiz	Spain
2	Hospital de Puerto Real	Puerto Real	Cádiz	Spain	11510
3	Fundacion Instituto de Investigacion Sanitaria de Santiago de Compostela	Santiago De Compostela	Galicia	Spain
4	Instituto de Investigacion En Recursos Cinegeticos (Irec)	Ciudad Real		Spain
5	Facultad de Veterinaria de Cordoba	Córdoba		Spain	14004
6	Fundacion Investigacion Biomedica de Cordoba (Fibico)	Córdoba		Spain	14004
7	Instituto Maimonides de Investigacion Biomedica de Cordoba (Imibic)	Córdoba		Spain	14004
8	Hospital Universitario San Cecilio	Granada		Spain
9	Clinica Universidad de Navarra	Madrid		Spain
10	Complejo Hospitalario de Especialidades Virgen de La Victoria	Málaga		Spain