ZIKAlliance Natural History Study

NCT ID: NCT03204409

Last Updated: 2022-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2021-09-30

Brief Summary

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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

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* 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.

Conditions

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Zika Virus Zika Virus Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Symptomatic adults

adult patients (\>18 years) presenting with febrile or rash illness of short duration (\<72h)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* presence of symptoms or complications indicative of a bacterial infection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role collaborator

University of Heidelberg Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Thomas Jaenisch

Senior Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Jänisch

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Locations

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University of Sao Paulo

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 31878895 (View on PubMed)

Other Identifiers

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734548NH (EC | H2020 | RIA)

Identifier Type: -

Identifier Source: org_study_id

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