ZIKAlliance Natural History Study

NCT03204409 — Withdrawn, University of Heidelberg Medical Center

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

Registry	NCT03204409, acronym ZIKAllianceNH
Status	Withdrawn - No ZIKA cases at study site
Study type	Observational
Sponsor	University of Heidelberg Medical Center (Other); collaborators: University of Sao Paulo
Conditions	Zika Virus, Zika Virus Infection
Dates	start 2018-04-01, primary completion 2021-09-30 (estimated), completion 2021-09-30 (estimated), first posted 2017-07-02, last updated 2022-05-18
Locations	1 site in Brazil

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Symptomatic adults			adult patients (>18 years) presenting with febrile or rash illness of short duration (<72h)

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Rash or Fever illness
* within 72 hours of symptom onset

Exclusion Criteria:

* presence of symptoms or complications indicative of a bacterial infection

+Locations (1)

Facility	City	Country	Status
University of Sao Paulo	São Paulo	Brazil

+Publications

Results publication: Avelino-Silva VI, Mayaud P, Tami A, Miranda MC, Rosenberger KD, Alexander N, Nacul L, Segurado A, Pohl M, Bethencourt S, Villar LA, Viana IFT, Rabello R, Soria C, Salgado SP, Gotuzzo E, Guzman MG, Martinez PA, Lopez-Gatell H, Hegewisch-Taylor J, Borja-Aburto VH, Gonzalez C, Netto EM, Saba Villarroel PM, Hoen B, Brasil P, Marques ETA, Rockx B, Koopmans M, de Lamballerie X, Jaenisch T; ZIKAlliance Clinical Study Group. Study protocol for the multicentre cohorts of Zika virus infection in pregnant women, infants, and acute clinical cases in Latin America and the Caribbean: the ZIKAlliance consortium. BMC Infect Dis. 2019 Dec 26;19(1):1081. doi: 10.1186/s12879-019-4685-9. PMID 31878895

+Investigators

Thomas Jänisch, Principal investigator, University Hospital Heidelberg

My Notes

Public

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