Clinical trial NCT05062967: Evaluation of Orthohepevirus C Infection as an Emerging Cause of Zoonotic Origin Disease
Official title: Evaluation of Orthohepevirus C Infection as an Emerging Cause of Zoonotic Origin Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis
Liver Diseases
Acute Hepatitis
Chronic Hepatitis
Liver Disease Chronic
Keywords: Orthohepevirus C
Hepatitis
Liver Diseases
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 3257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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

Eligibility 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)

Primary outcomes:
measure: Existence of Ortho-C infection
timeFrame: Yearly, up to three years.
Secondary outcomes:
Other outcomes:
Locations:
city: Jerez De La Frontera
country: Spain
facility: Hospital de Jerez de La Frontera
state: Cádiz
city: Puerto Real
country: Spain
facility: Hospital de Puerto Real
state: Cádiz
city: Santiago De Compostela
country: Spain
facility: Fundacion Instituto de Investigacion Sanitaria de Santiago de Compostela
state: Galicia
city: Ciudad Real
country: Spain
facility: Instituto de Investigacion En Recursos Cinegeticos (Irec)
city: Córdoba
country: Spain
facility: Facultad de Veterinaria de Cordoba
city: Córdoba
country: Spain
facility: Fundacion Investigacion Biomedica de Cordoba (Fibico)
city: Córdoba
country: Spain
facility: Instituto Maimonides de Investigacion Biomedica de Cordoba (Imibic)
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra
city: Málaga
country: Spain
facility: Complejo Hospitalario de Especialidades Virgen de La Victoria
Study officials:
affiliation: Hospital Universitario Reina Sofía
name: ANTONIO RIVERO ROMÁN
role: PRINCIPAL_INVESTIGATOR
References: