An observational study in Zika Virus, Zika Virus Disease and Virus Shedding, sponsored by Institute of Tropical Medicine, Belgium. Completed at 1 site in Belgium. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-03-02.
Sponsored by Institute of Tropical Medicine, Belgium · Observational
This is a prospective observational laboratory evaluation of the persistence rate of zika virus (ZIKV) infection in semen by real-time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), and assessment of ZIKV replication-competence in semen by isolation of ZIKV. Evaluation of the persistence of ZIKV and its replication-competence in semen samples will increase the understanding of the risk of sexual transmission of ZIKV infection in the post-viremic phase in non-epidemic settings.
Objectives
Study design, population, materials and methods: Prospective cohort study of persistence of zika virus (ZIKV) in semen samples of adult male patients who attend the outpatient clinic of the Institute of Tropical Medicine in Antwerp and who have a confirmed ZIKV infection (positive RT-PCR for ZIKV in a serum or urine sample at the time of inclusion). Clinical and epidemiological data will be recorded in a standardized Case Record Form (CRF). Baseline serum, blood and urine samples will be collected as required for routine clinical evaluation of an individual case and for arbovirus antibody detection assays; sampling of serum and urine collection for RT-PCR will be scheduled weekly until 2 consecutive semen samples test negative in ZIKV RT-PCR. ZIKV isolation will be attempted from each available semen sample with a positive PCR result. The semen analyses will include: sperm count, morphology, motility, leukocyte and erythrocyte count and pH of the semen. Serum at 4 weeks will be collected for ZIKV antibody detection assay.
Sample size : panel of 20 ZIKV confirmed cases Endpoints: Proportion of ZIKV positive RT-PCR on semen samples over time after confirmation of acute ZIKV infection, positivity rates of ZIKV isolation from semen samples over time after acute ZIKV infection.
Expected results and relevance : Evaluation of the persistence of ZIKV and its replication-competence in semen samples will increase the understanding of the risk of sexual transmission of ZIKV infection in the post-viremic phase in non-epidemic settings. This evidence will contribute to a more rational advice on preventing sexual transmission of ZIKV infection.
914 studies on the registry are indexed under Virus Diseases; 110 are open to participants now.
This study's enrollment of 15 is below the median of 300 across 275 observational studies indexed under Virus Diseases.
Browse Virus Diseases studies →Institute of Tropical Medicine, Belgium is the lead sponsor of 103 studies on the registry; 22 are open to participants now.
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men of 18 years or older, with confirmed ZIKV infection, residing in areas without epidemiologically important arthropod-borne ZIKV transmission
Confirmed ZIKV case, defined as:
Exclusion Criteria:
Incidence rate of ZIKV persistence in semen
proportion of ZIKV positive semen samples in adult male patients after acute ZIKV infection over time
Time frame: weekly followup (until 2 consecutive negative PCR results)- up to 6 months
kinetics of ZIKV persistence in semen
kinetics of ZIKV in semen samples by means of RT-PCR Cycle threshold (Ct-value) results after acute ZIKV infection over time
Time frame: weekly followup (until 2 consecutive negative PCR results)- up to 6 months
replication fitness of ZIKV in semen
assess replication fitness of ZIKV in semen, by isolation
Time frame: weekly followup (until 2 consecutive negative PCR results)- up to 6 months
comparison of ZIKV sequences from semen vs. non-semen samples
comparison of ZIKV sequences of virus isolated from semen vs. non-semen samples to detect potential compartmentalization
Time frame: weekly followup (until 2 consecutive negative PCR results)- up to 6 months
Plan to share: Yes — Yes, de-identified individual participant data will be made available for all primary and secondary study outcomes within 6 months of study completion
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Institute of Tropical Medicine, Belgium