Dermatologic Manifestations of Zika Virus | NCT03229421

Studies
Dermatologic Manifestations of Zika Virus

NCT03229421

Sponsor

Northwestern University

Status

Withdrawn

Last Update Posted

Feb 4, 2019Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Zika Virus Symptoms and the Associated Exanthema

Interventions

Survey

Countries

Dominican Republic

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to enroll eligible participants

Expanded Access Info

Start Date

Jul 6, 2017Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Jul 18, 2017

First Submission Date that Met QC Criteria

Jul 21, 2017

First Posted Date

Jul 25, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2019

Last Update Posted Date

Feb 4, 2019Actual

Name	Class
Pontificia Universidad Catolica Madre y Maestra	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Survey	Other	18 question symptom assessment tool including non-identifying demographic information questions.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of days with specific symptoms	Number of days reported experiencing specific symptoms due to Zika Virus infection and and associated characteristics such as location and intensity	20 minutes

Secondary Outcomes

Measure	Description	Time Frame
Frequency measures of initial clinical presentations	Frequency of reported symptoms at initial clinical presentation.	20 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients aged 17 years or younger

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults 18 y/o with confirmed zika virus diagnosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roopal V. Kundu, MD	Northwestern University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pontificia Universidad Catolica Madre y Maestra, Departamento de Medicina		Santo Domingo	Illinois		Dominican Republic

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000071243	Zika Virus Infection

Ancestor Terms

ID	Term
D000096724	Mosquito-Borne Diseases
D000079426	Vector Borne Diseases
D007239	Infections
D001102	Arbovirus Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided