Zika Virus Clinical Trial
Official title:
Persistence of Zika Virus in Semen After Acute Infection
Verified date | March 2021 |
Source | Institute of Tropical Medicine, Belgium |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
Status | Completed |
Enrollment | 15 |
Est. completion date | September 1, 2017 |
Est. primary completion date | May 1, 2017 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Male sex - Age 18 years or older - Confirmed ZIKV case, defined as: - Having traveled to an affected area and developing at least 2 of the following Zika virus disease compatible symptoms within 2 weeks of travel: fever defined as T= 37.8°C (axillary measurement), maculopapular rash, arthralgia or non-purulent conjunctivitis. - Zika virus diagnosis by:RNA detection by RT-PCR in serum or urine during the first 10 days after infection, OR Four-fold or greater change in virus-specific quantitative antibody titers in paired sera, OR Virus-specific Immunoglobulin M (IgM) antibodies in serum with confirmatory virus-specific neutralizing antibodies in the same or a later specimen Exclusion Criteria: - History of, or ongoing urologic malignancy or urologic surgical treatment (including vasectomy). - Recent (< 2 years) history of, or ongoing urinary tract infection (including prostatitis, epididymitis, sexually transmitted diseases). |
Country | Name | City | State |
---|---|---|---|
Belgium | ITM | Antwerp |
Lead Sponsor | Collaborator |
---|---|
Institute of Tropical Medicine, Belgium |
Belgium,
Barzon L, Pacenti M, Franchin E, Pagni S, Martello T, Cattai M, Cusinato R, Palù G. Excretion of West Nile virus in urine during acute infection. J Infect Dis. 2013 Oct 1;208(7):1086-92. doi: 10.1093/infdis/jit290. Epub 2013 Jul 2. — View Citation
Foy BD, Kobylinski KC, Chilson Foy JL, Blitvich BJ, Travassos da Rosa A, Haddow AD, Lanciotti RS, Tesh RB. Probable non-vector-borne transmission of Zika virus, Colorado, USA. Emerg Infect Dis. 2011 May;17(5):880-2. doi: 10.3201/eid1705.101939. — View Citation
Gourinat AC, O'Connor O, Calvez E, Goarant C, Dupont-Rouzeyrol M. Detection of Zika virus in urine. Emerg Infect Dis. 2015 Jan;21(1):84-6. doi: 10.3201/eid2101.140894. — View Citation
Hirayama T, Mizuno Y, Takeshita N, Kotaki A, Tajima S, Omatsu T, Sano K, Kurane I, Takasaki T. Detection of dengue virus genome in urine by real-time reverse transcriptase PCR: a laboratory diagnostic method useful after disappearance of the genome in serum. J Clin Microbiol. 2012 Jun;50(6):2047-52. doi: 10.1128/JCM.06557-11. Epub 2012 Mar 21. — View Citation
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Musso D, Roche C, Robin E, Nhan T, Teissier A, Cao-Lormeau VM. Potential sexual transmission of Zika virus. Emerg Infect Dis. 2015 Feb;21(2):359-61. doi: 10.3201/eid2102.141363. Erratum in: Emerg Infect Dis. 2015 Mar;21(3):552. — View Citation
Oster AM, Brooks JT, Stryker JE, Kachur RE, Mead P, Pesik NT, Petersen LR. Interim Guidelines for Prevention of Sexual Transmission of Zika Virus - United States, 2016. MMWR Morb Mortal Wkly Rep. 2016 Feb 12;65(5):120-1. doi: 10.15585/mmwr.mm6505e1. — View Citation
Poloni TR, Oliveira AS, Alfonso HL, Galvão LR, Amarilla AA, Poloni DF, Figueiredo LT, Aquino VH. Detection of dengue virus in saliva and urine by real time RT-PCR. Virol J. 2010 Jan 27;7:22. doi: 10.1186/1743-422X-7-22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence rate of ZIKV persistence in semen | proportion of ZIKV positive semen samples in adult male patients after acute ZIKV infection over time | weekly followup (until 2 consecutive negative PCR results)- up to 6 months | |
Secondary | 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 | weekly followup (until 2 consecutive negative PCR results)- up to 6 months | |
Secondary | replication fitness of ZIKV in semen | assess replication fitness of ZIKV in semen, by isolation | weekly followup (until 2 consecutive negative PCR results)- up to 6 months | |
Secondary | 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 | weekly followup (until 2 consecutive negative PCR results)- up to 6 months |
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