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ZIKAlliance Natural History Study (ZIKAllianceNH)

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ClinicalTrials.gov Identifier: NCT03204409
Recruitment Status : Not yet recruiting
First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Thomas Jaenisch, 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.

Condition or disease
Zika Virus Zika Virus Infection

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.

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Clinical and Virological Study Among Symptomatic Patients With Zika Virus Infection in the City of Sao Paulo, Brazil
Estimated Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : September 3, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Zika Virus

Group/Cohort
Symptomatic adults
adult patients (>18 years) presenting with febrile or rash illness of short duration (<72h)



Primary Outcome Measures :
  1. ZIKA Virus Infection [ Time Frame: up to one year ]
    Clinical Characterization

  2. DENGUE Virus Infection [ Time Frame: up to one year ]
    Clinical Characterization

  3. Chikungunya Virus Infection [ Time Frame: up to one year ]
    Clinical Characterization


Biospecimen Retention:   Samples With DNA
blood, saliva, urine and genital fluid samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
General Population
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • presence of symptoms or complications indicative of a bacterial infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03204409


Contacts
Contact: Thomas Jänisch +49 6221 56 38040 thomas.jaenisch@urz.uni-heidelberg.de

Locations
Brazil
University of Sao Paulo Not yet recruiting
São Paulo, Brazil
Contact: Vivian Avelino-Silva       vivian87@usp.br   
Contact: Aluisio Cotrim Segurado       segurado@usp.br   
Sponsors and Collaborators
University of Heidelberg Medical Center
University of Sao Paulo
Investigators
Principal Investigator: Thomas Jänisch University Hospital Heidelberg

Responsible Party: Thomas Jaenisch, Senior Scientist, University of Heidelberg Medical Center
ClinicalTrials.gov Identifier: NCT03204409     History of Changes
Other Study ID Numbers: 734548NH (EC | H2020 | RIA)
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thomas Jaenisch, University of Heidelberg Medical Center:
CHIKV
DENGUE
Chikungunya
DENV

Additional relevant MeSH terms:
Infection
Virus Diseases
Zika Virus Infection
Arbovirus Infections
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections