Oropouche Infection
Conditions
Brief summary
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.
Detailed description
This is a study with retrospective and prospective enrollment.
Interventions
None listed
Sponsors
IRCCS Sacro Cuore Don Calabria di Negrar
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-OROV serum antibody response | Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO | Results of the anti-OROV serum antibody response along the study period: * IgM (titer, reciprocal of dilution); * IgG (titer, reciprocal of dilution). |
| OROV viral RNA shedding in different matrices | Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of anti-OROV cytokine production | Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO. | Results of the quality of anti-OROV cytokine production profile along the study period: cytokine analysis (pg/ml) |
| Timing evolution of humoral OROV specific response | Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO | IgM and IgG kinetics (days from symptoms onset or first diagnosis). |
| Quality of anti-OROV humoral response | Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO. | Results of the anti-OROV neutralizing antibody response along the study period: neutralizing antibodies titer (titer, reciprocal of dilution). |
| Semi-quantitative OROV RNA viral loads evaluation | Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO | Results of OROV RT-PCR testing results by cycle threshold (Ct) values along the study period: RT-PCR (Ct) |
| Quantitative OROV RNA viral load evaluation | Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO | Results of OROV RNA copies along the study period: ddPCR (copies/mL) |
| Time duration limits of RT-PCR-positivity persistence in different matrices | Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO | RT-PCR positivity persistence (days from symptoms onset or first diagnosis) |
| Quality of anti-OROV cell mediated immunity evolution | Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO | Results of the quality of anti-OROV cell mediatedimmune response along the study period: specific cell-mediated response (specific IFN producing cells/100,000). |
Countries
Italy
Contacts
Primary ContactElvia Malo
Outcome results
None listed