Study on the Persistence of Zika Virus (ZIKV) in Body Fluids of Patients With ZIKV Infection in Brazil (ZikaBra)
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|ClinicalTrials.gov Identifier: NCT03106714|
Recruitment Status : Active, not recruiting
First Posted : April 10, 2017
Last Update Posted : August 13, 2019
The Zika infection is a viral disease that is transmitted to humans by the same mosquito that transmits Dengue and Chikungunya fever. The Zika virus has been found in various body fluids such as urine, blood and semen, but we do not know how long it persists in these fluids. For example, parts of the virus were reported to persist in semen after six months of the onset of symptoms, but we do not know if the virus can stay longer. In this way, we want to investigate how long the Zika virus can be found in other secretions besides blood and urine.
Study Hypothesis: ZIKV can be shed in human body fluids long after the time of the acute infection. Persistence of ZIKV in different body fluids may vary due to the influence of circulating specific ZIKV IgM and IgG, as well as host and environmental factors.
|Condition or disease||Intervention/treatment|
|Zika Virus||Diagnostic Test: RT-PCR|
Little is known about Zika virus (ZIKV) biology and its pathogenesis in humans. ZIKV has been detected in blood, urine, semen, cerebral spinal fluid, saliva, amniotic fluid, and breast milk. In most ZIKV infected individuals, the virus is detected in the blood from a several days to one week after the onset of symptoms and has also been found to persist longer in urine and semen. Without a more granular understanding of the kinetics of ZIKV infection across biologic compartments it will be difficult to devise rational measures to prevent the transmission of the virus.
This will be an observational cohort study of men and women, aged 18 years and above, including symptomatic participants with positive reverse transcriptase-polymerase chain reaction (RT-PCR) test in blood and/or urine and their symptomatic or asymptomatic household/sexual contacts with positive RT-PCR in blood and/or urine. Specimens to be collected at pre-established intervals and tested for ZIKV RNA by RT-PCR are blood, semen, vaginal secretions, oral fluid (saliva and crevicular fluid), tears, sweat, urine, rectal swab, menstrual blood and breast milk (if applicable). Participants will be recruited from collaborating clinics in selected locations with high population density, high circulation of the virus, strong community network, and serviced by laboratory facilities with capacity to perform the necessary tests.
All participants will be followed up for 12 months, to assess detectability at longer time intervals, reactivation or reinfection. Analyses of antibody response, including circulating immunoglobulins M and G (IgM and IgG), will be performed in parallel to RT-PCR tests. Plaque reduction neutralization test will be performed in specimens of participants who are found to be simultaneously positive for ZIKV and dengue.
Specific analysis will be performed to determine if socio-demographic characteristics, comorbidities and co-infections influence the persistence of the virus in the body fluids.
|Study Type :||Observational|
|Estimated Enrollment :||1300 participants|
|Official Title:||Study on the Persistence of Zika Virus (ZIKV) in Body Fluids of Patients With ZIKV Infection in Brazil|
|Actual Study Start Date :||July 21, 2017|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||July 31, 2020|
Detectable RT-PCR ZIKV
Men and women aged 18 years and above with diagnosis of ZIKV infection
Diagnostic Test: RT-PCR
Persistence of detectable Zika virus (by RT-PCR test) in all selected body fluids
- Persistence and duration of ZIKV [ Time Frame: 12 months of follow-up after ZIKV infection diagnosis ]Persistence and duration of ZIKV in each body fluid in infected symptomatic and asymptomatic participants.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03106714
|Tropical Medicine Foundation|
|Manaus, Amazonas, Brazil, 69040000|
|Research Centre Aggeu Magalhães, Oswaldo Cruz Foundation|
|Recife, Pernambuco, Brazil, 50670-420|
|Evandro Chagas National Institute of Infectious Diseases - Oswaldo Cruz Foundation|
|Rio de Janeiro, Brazil, 21040-360|
|Study Chair:||Nathalie JN Broutet, MD, PhD||Department of Reproductive Health and Research World Health Organization|
|Principal Investigator:||Ana Maria B de Filippis, PhD||Oswaldo Cruz Foundation (Flavivirus Diagnostic and Reference Laboratory-Oswaldo Cruz Institute- Rio de Janeiro)|
|Principal Investigator:||Guilherme A Calvet, MD,PhD||Oswaldo Cruz Foundation (Evandro Chagas National Institute of Infectious Diseases- Rio de Janeiro)|
|Principal Investigator:||Rafael FO França, PhD||Oswaldo Cruz Foundation (Research Centre Aggeu Magalhães- Recife)|
|Principal Investigator:||Marcus VG Lacerda, MD,PhD||Tropical Medicine Foundation, Manaus|