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

NCT03106714 | Completed

• 8 other identifiers: ERC.000278662518016.6.1001.0008R21AI139777TSA1-2017/720873-0TSA2-2017/731359-0206522/Z/17/ZConvênio 837059/2016W81XWH-18-2-0040
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 3

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.

Conditions

Zika Virus

Keywords

persistence; body fluids

Outcome Measures

Primary Outcomes (1)

• Persistence and duration of ZIKV

  Persistence and duration of ZIKV in each body fluid in infected symptomatic and asymptomatic participants.

  12 months of follow-up after ZIKV infection diagnosis

Study Arms (1)

Detectable RT-PCR ZIKV

Men and women aged 18 years and above with diagnosis of ZIKV infection

Diagnostic Test: RT-PCR

Interventions

RT-PCR DIAGNOSTIC_TEST

Persistence of detectable Zika virus (by RT-PCR test) in all selected body fluids

Detectable RT-PCR ZIKV

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

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.

You may qualify if:

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

You may not qualify if:

• As per index case

Sponsors & Collaborators

• Oswaldo Cruz Foundation: lead
• World Health Organization: collaborator
• Ministry of Health, Brazil: collaborator
• Walter Reed Army Institute of Research (WRAIR): collaborator
• Wellcome Trust: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (3)

Tropical Medicine Foundation

Manaus, Amazonas, 69040000, Brazil

Location

Research Centre Aggeu Magalhães, Oswaldo Cruz Foundation

Recife, Pernambuco, 50670-420, Brazil

Location

Evandro Chagas National Institute of Infectious Diseases - Oswaldo Cruz Foundation

Rio de Janeiro, 21040-360, Brazil

Location

Related Publications (4)

• Calvet GA, Kara EO, Giozza SP, Botto-Menezes CHA, Gaillard P, de Oliveira Franca RF, de Lacerda MVG, da Costa Castilho M, Brasil P, de Sequeira PC, de Mello MB, Bermudez XPD, Modjarrad K, Meurant R, Landoulsi S, Benzaken AS, de Filippis AMB, Broutet NJN; ZIKABRA Study Team. Study on the persistence of Zika virus (ZIKV) in body fluids of patients with ZIKV infection in Brazil. BMC Infect Dis. 2018 Jan 22;18(1):49. doi: 10.1186/s12879-018-2965-4.

  PMID: 29357841 BACKGROUND

• Menezes-Neto A, Castilho MDC, Calvet GA, Kara EO, Botto-Menezes CHA, Lacerda MVG, Pereira GFM, Giozza SP, Bermudez XPD, Lima NS, Modjarrad K, Broutet N, de Filippis AMB, Franca RFO; Study Team ZIKABRA. Zika virus RNA excretion in sweat with concomitant detection in other body fluid specimens. Mem Inst Oswaldo Cruz. 2021 Jan 25;115:e200339. doi: 10.1590/0074-02760200339. eCollection 2021.

  PMID: 33503145 RESULT

• Calvet GA, Kara EO, Landoulsi S, Habib N, Botto-Menezes CHA, Franca RFO, Neto AM, Castilho MDC, Fernandes TJ, Pereira GF, Giozza SP, Bermudez XPD, Modjarrad K, Lima N, Brasil P, de Lacerda MVG, de Filippis AMB, Broutet NJN; ZIKABRA Study Team. Cohort profile: Study on Zika virus infection in Brazil (ZIKABRA study). PLoS One. 2021 Jan 5;16(1):e0244981. doi: 10.1371/journal.pone.0244981. eCollection 2021.

  PMID: 33400705 RESULT

• Botto-Menezes CHA, Neto AM, Calvet GA, Kara EO, Lacerda MVG, Castilho MDC, Stroher U, Antunes de Brito CA, Modjarrad K, Broutet N, Brasil P, Bispo de Filippis AM, Franca RFO; ZIKABRA Study Team. Zika Virus in Rectal Swab Samples. Emerg Infect Dis. 2019 May;25(5):951-954. doi: 10.3201/eid2505.180904.

  PMID: 31002058 RESULT

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

MeSH Terms

Conditions

Zika Virus Infection

Interventions

COVID-19 Nucleic Acid Testing

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

COVID-19 Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Nathalie JN Broutet, MD, PhD

  Department of Reproductive Health and Research World Health Organization

  STUDY CHAIR

• Ana Maria B de Filippis, PhD

  Oswaldo Cruz Foundation (Flavivirus Diagnostic and Reference Laboratory- 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 10, 2017
• Study Start: July 21, 2017
• Primary Completion: June 26, 2020
• Study Completion: June 26, 2020
• Last Updated: March 3, 2021

Record last verified: 2021-02

Locations

BR (3)