An observational study in Oropouche Infection, sponsored by IRCCS Sacro Cuore Don Calabria di Negrar. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-18.
Sponsored by IRCCS Sacro Cuore Don Calabria di Negrar · Observational
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.
This is a study with retrospective and prospective enrollment.
IRCCS Sacro Cuore Don Calabria di Negrar is the lead sponsor of 38 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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 the Center.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Anti-OROV serum antibody response
Results of the anti-OROV serum antibody response along the study period: * IgM (titer, reciprocal of dilution); * IgG (titer, reciprocal of dilution).
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
OROV viral RNA shedding in different matrices
Results of OROV viral RNA presence in different matrice along the study period: RT-PCR Ct and RNA copies/mL in different matrices: urine, whole blood, serum, vaginal swab or seminal fluid, CSF and amniotic fluid if available.
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Quality of anti-OROV humoral response
Results of the anti-OROV neutralizing antibody response along the study period: neutralizing antibodies titer (titer, reciprocal of dilution).
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO.
Quality of anti-OROV cell mediated immunity evolution
Results of the quality of anti-OROV cell mediatedimmune response along the study period: specific cell-mediated response (specific IFN producing cells/100,000).
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Quality of anti-OROV cytokine production
Results of the quality of anti-OROV cytokine production profile along the study period: cytokine analysis (pg/ml)
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO.
Timing evolution of humoral OROV specific response
IgM and IgG kinetics (days from symptoms onset or first diagnosis).
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Time duration limits of RT-PCR-positivity persistence in different matrices
RT-PCR positivity persistence (days from symptoms onset or first diagnosis)
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Semi-quantitative OROV RNA viral loads evaluation
Results of OROV RT-PCR testing results by cycle threshold (Ct) values along the study period: RT-PCR (Ct)
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Quantitative OROV RNA viral load evaluation
Results of OROV RNA copies along the study period: ddPCR (copies/mL)
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bunyaviridae Infections
IRCCS Sacro Cuore Don Calabria di Negrar