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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 8 March 2021
Main ID:  NCT03106714
Date of registration: 03/04/2017
Prospective Registration: Yes
Primary sponsor: Oswaldo Cruz Foundation
Public title: Study on the Persistence of Zika Virus (ZIKV) in Body Fluids of Patients With ZIKV Infection in Brazil ZikaBra
Scientific title: Study on the Persistence of Zika Virus (ZIKV) in Body Fluids of Patients With ZIKV Infection in Brazil
Date of first enrolment: July 21, 2017
Target sample size: 260
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03106714
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Brazil
Contacts
Name:     Marcus VG Lacerda, MD,PhD
Address: 
Telephone:
Email:
Affiliation:  Tropical Medicine Foundation, Manaus
Name:     Guilherme A Calvet, MD,PhD
Address: 
Telephone:
Email:
Affiliation:  Oswaldo Cruz Foundation (Evandro Chagas National Institute of Infectious Diseases- Rio de Janeiro)
Name:     Rafael FO França, PhD
Address: 
Telephone:
Email:
Affiliation:  Oswaldo Cruz Foundation (Research Centre Aggeu Magalhães- Recife)
Name:     Nathalie JN Broutet, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Department of Reproductive Health and Research World Health Organization
Name:     Ana Maria B de Filippis, PhD
Address: 
Telephone:
Email:
Affiliation:  Oswaldo Cruz Foundation (Flavivirus Diagnostic and Reference Laboratory- Rio de Janeiro)
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Zika Virus
Intervention(s)
Diagnostic Test: RT-PCR
Primary Outcome(s)
Persistence and duration of ZIKV [Time Frame: 12 months of follow-up after ZIKV infection diagnosis]
Secondary Outcome(s)
Secondary ID(s)
TSA2-2017/731359-0
ERC.0002786
R21AI139777
TSA1-2017/720873-0
206522/Z/17/Z
Convênio 837059/2016
W81XWH-18-2-0040
62518016.6.1001.0008
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
World Health Organization
Wellcome Trust
Ministry of Health, Brazil
Walter Reed Army Institute of Research (WRAIR)
National Institute of Allergy and Infectious Diseases (NIAID)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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