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NCT03204409 Clinical Trial

ZIKAlliance Natural History Study

Zika Virus Infection Clinical Trial

— ZIKAllianceNH  

Official title:
Longitudinal Clinical and Virological Study Among Symptomatic Patients With Zika Virus Infection in the City of Sao Paulo, Brazil

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03204409
Other study ID # 734548NH (EC | H2020 | RIA)
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date April 1, 2018
Est. completion date September 30, 2021

Study information
Verified date May 2022
Source University of Heidelberg Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Study to enroll up to 1000 adult patients (>18 years) presenting with febrile or rash illness of short duration (<72h) in designated clinics in the State of Sao Paulo, Brazil.

Description:

- Study to enroll up to 1000 adult patients (>18 years) presenting with febrile or rash illness of short duration (<72h) in designated clinics in the State of Sao Paulo, Brazil. - Following enrolment (day 0), patients will be followed up at days 2-3, 7, 14, 21, 30, 90, 180 and 360 with clinical and biological procedures (blood and urine samples). - For patients with proven ZIKA Virus (ZIKV) infection, follow-up samples will include blood, saliva, urine and genital samples. - For non-ZIKV infected patients, follow-up samples will include serological monitoring at days 14, 30, 180 and 360, and for men, possible assessment of genital fluids at day 180. - All patients will be evaluated for impact on disability up to one year. Household adult contacts of ZIKV patients will be invited for ZIKV evaluation including collection of blood and urine samples.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Rash or Fever illness - within 72 hours of symptom onset Exclusion Criteria: - presence of symptoms or complications indicative of a bacterial infection

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Brazil University of Sao Paulo São Paulo

Sponsors (2)
Lead Sponsor Collaborator
University of Heidelberg Medical Center University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary ZIKA Virus Infection Clinical Characterization up to one year
Primary DENGUE Virus Infection Clinical Characterization up to one year
Primary Chikungunya Virus Infection Clinical Characterization up to one year
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