ZIKAlliance Natural History Study
- Conditions
- Zika VirusZika Virus Infection
- Registration Number
- NCT03204409
- Lead Sponsor
- University of Heidelberg Medical Center
- Brief 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.
- Detailed 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 & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Rash or Fever illness
- within 72 hours of symptom onset
- presence of symptoms or complications indicative of a bacterial infection
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ZIKA Virus Infection up to one year Clinical Characterization
DENGUE Virus Infection up to one year Clinical Characterization
Chikungunya Virus Infection up to one year Clinical Characterization
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Sao Paulo
🇧🇷São Paulo, Brazil