Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT05062967
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
Study:
NCT05062967
Study Brief:
Protocol Section:
NCT05062967