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Dermatologic Manifestations of Zika Virus (DMZV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03229421
Recruitment Status : Withdrawn (Unable to enroll eligible participants)
First Posted : July 25, 2017
Last Update Posted : February 4, 2019
Sponsor:
Collaborator:
Pontificia Universidad Catolica Madre y Maestra
Information provided by (Responsible Party):
Roopal Kundu, Northwestern University

Study Description
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Brief Summary:
The purpose of this study is to determine whether any diagnostic patterns exist in the symptom presentation of Zika Virus.

Condition or disease Intervention/treatment
Zika Virus Symptoms and the Associated Exanthema Other: Survey

Detailed Description:
The study has both retrospective and prospective components. The retrospective review includes medical records with laboratory confirmed Zika Virus diagnosis and the prospective component will enroll adults presenting with febrile illness and rash and ask them to complete a survey about their symptoms. Diagnostic testing will be completed to confirm infection source.
Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Survey of Symptoms and Dermatologic Characterization Associated With Zika Virus
Actual Study Start Date : July 6, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Zika Virus

Groups and Cohorts
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Intervention Details:
  • Other: Survey
    18 question symptom assessment tool including non-identifying demographic information questions.

Outcome Measures
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Primary Outcome Measures :
  1. Number of days with specific symptoms [ Time Frame: 20 minutes ]
    Number of days reported experiencing specific symptoms due to Zika Virus infection and and associated characteristics such as location and intensity


Secondary Outcome Measures :
  1. Frequency measures of initial clinical presentations [ Time Frame: 20 minutes ]
    Frequency of reported symptoms at initial clinical presentation.


Eligibility Criteria
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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
Adults 18 y/o with confirmed zika virus diagnosis
Criteria

Inclusion Criteria:

  • Adults aged 18 years and older presenting with febrile illness and rash

Exclusion Criteria:

  • Patients aged 17 years or younger
Contacts and Locations
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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): NCT03229421


Locations
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Dominican Republic
Pontificia Universidad Catolica Madre y Maestra, Departamento de Medicina
Santo Domingo, Illinois, Dominican Republic
Sponsors and Collaborators
Northwestern University
Pontificia Universidad Catolica Madre y Maestra
Investigators
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Principal Investigator: Roopal V. Kundu, MD Northwestern University
More Information
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Responsible Party: Roopal Kundu, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT03229421    
Other Study ID Numbers: STU00205325
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roopal Kundu, Northwestern University:
Zika Virus
Additional relevant MeSH terms:
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Zika Virus Infection
Exanthema
Virus Diseases
Arbovirus Infections
 Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Skin Diseases