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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05062967
Other study ID # PI21/00793
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date December 1, 2024

Study information

Verified date September 2021
Source Maimónides Biomedical Research Institute of Córdoba
Contact ANTONIO RIVERO ROMÁN
Phone 957012421
Email ariveror@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 3257
Est. completion date December 1, 2024
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
Spain Instituto de Investigacion En Recursos Cinegeticos (Irec) Ciudad Real
Spain Facultad de Veterinaria de Cordoba Córdoba
Spain Fundacion Investigacion Biomedica de Cordoba (Fibico) Córdoba
Spain Instituto Maimonides de Investigacion Biomedica de Cordoba (Imibic) Córdoba
Spain Hospital Universitario San Cecilio Granada
Spain Hospital de Jerez de La Frontera Jerez De La Frontera Cádiz
Spain Clinica Universidad de Navarra Madrid
Spain Complejo Hospitalario de Especialidades Virgen de La Victoria Málaga
Spain Hospital de Puerto Real Puerto Real Cádiz
Spain Fundacion Instituto de Investigacion Sanitaria de Santiago de Compostela Santiago De Compostela Galicia

Sponsors (1)

Lead Sponsor Collaborator
Maimónides Biomedical Research Institute of Córdoba

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Existence of Ortho-C infection 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.
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