Other Clinical Trial - Evaluation of Orthohepevirus C Infection as an

Status Not yet recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05062967
Study type	Observational [Patient Registry]
Source	Maimónides Biomedical Research Institute of Córdoba
Contact	ANTONIO RIVERO ROMÁN
Phone	957012421
Email	ariveror@gmail.com
Status	Not yet recruiting
Phase
Start date	January 1, 2022
Completion date	December 1, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms