NCT03204409

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

3.5 years

First QC Date

June 29, 2017

Last Update Submit

May 17, 2022

Conditions

Keywords

CHIKVDENGUEChikungunyaDENV

Outcome Measures

Primary Outcomes (3)

  • ZIKA Virus Infection

    Clinical Characterization

    up to one year

  • DENGUE Virus Infection

    Clinical Characterization

    up to one year

  • Chikungunya Virus Infection

    Clinical Characterization

    up to one year

Study Arms (1)

Symptomatic adults

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

General Population

You may qualify if:

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

You may not qualify if:

  • presence of symptoms or complications indicative of a bacterial infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo

São Paulo, Brazil

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

blood, saliva, urine and genital fluid samples

MeSH Terms

Conditions

Zika Virus InfectionDengueChikungunya Fever

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, ViralAlphavirus InfectionsTogaviridae Infections

Study Officials

  • Thomas Jänisch

    University Hospital Heidelberg

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

June 29, 2017

First Posted

July 2, 2017

Study Start

April 1, 2018

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations