OBSERVATIONAL STUDY ON VIRAL SHEDDING AND IMMUNOLOGICAL RESPONSE OF OROPOUCHE VIRUS (OROVIMM)

IRCCS Sacro Cuore Don Calabria di Negrar

Status: Enrolling

Conditions: Oropouche Infection

Study type: Observational

Funder types: Other

Identifiers

NCT06892015

2024-ZN

Details and patient eligibility

About

This is a single-center observational study, whose primary objective is to describe the immune response to Oropouche Virus (OROV) during the study period and the duration of viral RNA shedding, only for sequential samples, by RT-PCR in different matrices.

Full description

This is a study with retrospective and prospective enrollment.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• patients resulted positive to the RT-PCR for OROV;
• informed consent to the participation to the study and to personal data's treatment and/or donation of residual samples to Tropika Biobank;
• patients ≥ 18 years old.

Exclusion Criteria

• lack of signed informed consent.

Trial design

30 participants in 1 patient group

OROV patients

Description:

The study population will consist of adult patients (age 18 years or over) with RT-PCR-confirmed OROV, who attended or will attend health services at DITM. During first clinical encounter, study participants will be interviewed and physically examined as part of routine clinical practice, in this occasion patients will be also approached to obtain informed consent by their attending physician; all the patients will also be asked the consent for the donation of residual samples from routine diagnostic tests to Tropica BioBank. RT-PCR and culture testing will be repeated at each clinical visit and will stop when one negative RT-PCR results from all matrices have been obtained. Immunologic testing will continue for the duration of the study. Subject participation duration will be about 3 months in total.