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Study on the Persistence of Zika Virus (ZIKV) in Body Fluids of Patients With ZIKV Infection in Brazil (ZikaBra)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03106714
Recruitment Status : Active, not recruiting
First Posted : April 10, 2017
Last Update Posted : August 13, 2019
Sponsor:
Collaborators:
World Health Organization
Ministry of Health, Brazil
Walter Reed Army Institute of Research (WRAIR)
Wellcome Trust
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Guilherme Amaral Calvet, Oswaldo Cruz Foundation

Brief Summary:

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

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 1300 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Zika Virus

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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
Samples with DNA: whole blood and PBMC Also collected and stored: serum, semen, saliva, crevicular fluid, urine, vaginal secretions, menstrual blood, rectal swab, tears, sweat and breast milk


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This is a prospective observational cohort study. After signing a screening consent, male and female potential study participants presenting rash compatible with ZIKV infection in collaborating clinics will be tested for the presence of ZIKV in blood and urine. The following day, after providing informed consent for enrolment, those found to be RT-PCR positive for ZIKV infection, fulfilling all inclusion criteria will be enrolled and subject of regular collection of body fluids over a period of 12 months according to a pre-established schedule. Household/sexual contacts will be screened at the reference centers where the index case was diagnosed or if preferable at their household, and recruited following the same criteria. The standard care will be provided to all participants.
Criteria

Index Case - Enrolment Inclusion criteria

  • RT-PCR test positive for ZIKV in blood and/or urine specimens
  • Having given consent to provide all body fluid collection, as per protocol

Exclusion criteria RT-PCR test negative for ZIKV in blood and/or urine specimens

Household contacts enrollment (or sexual contacts if index case lives alone) Inclusion criteria

  • As per index case Exclusion criteria
  • As per index case

Information from the National Library of Medicine

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


Locations
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Brazil
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
Sponsors and Collaborators
Oswaldo Cruz Foundation
World Health Organization
Ministry of Health, Brazil
Walter Reed Army Institute of Research (WRAIR)
Wellcome Trust
National Institutes of Health (NIH)
Investigators
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guilherme Amaral Calvet, MD, PhD, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier: NCT03106714     History of Changes
Other Study ID Numbers: ERC.0002786
62518016.6.1001.0008 ( Other Identifier: Brazil National Commission for Research Ethics )
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guilherme Amaral Calvet, Oswaldo Cruz Foundation:
persistence
body fluids
Additional relevant MeSH terms:
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Zika Virus Infection
Virus Diseases
Arbovirus Infections
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections