OBSERVATIONAL STUDY ON VIRAL SHEDDING AND IMMUNOLOGICAL RESPONSE OF OROPOUCHE VIRUS

NCT06892015 | Recruiting

• 1 other identifier: 2024-ZN
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Oropouche Infection

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO

Secondary Outcomes (7)

• 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.

• 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

• 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.

• 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

• 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

Study Arms (1)

OROV patients

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• lack of signed informed consent.

Sponsors & Collaborators

• IRCCS Sacro Cuore Don Calabria di Negrar: lead

Study Sites (1)

IRCCS Sacro Cuore Don Calabria

Negrar, VR, 37024, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

The following clinical specimens will be collected: 1. Urine (10mL) 2. Whole Blood (EDTA tube 2x7mL) 3. Serum (2x7mL) 4. CSF (1mL) - only if the physician requires this sampling as per normal clinical practice, based on the patient's clinical presentation 5. Amniotic fluid (5mL) - only if the physician requires this sampling as per normal clinical practice, based on the patient's clinical presentation 6. Seminal fluid (1mL) - this sample is not mandatory, we will collect them only from subjects agreeing to donate. 7. Vaginal swab in UTM medium - this sample is not mandatory, we will collect them only from subjects agreeing to donate.

MeSH Terms

Conditions

Bunyaviridae Infections

Condition Hierarchy (Ancestors)

RNA Virus Infections; Virus Diseases; Infections

Central Study Contacts

Elvia Malo

CONTACT

+390456013111; ricerca.clinica@sacrocuore.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 24, 2025
• Study Start: December 19, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-03

Locations

IT (1)