Zika Virus Symptoms and the Associated ExanthemaDMZVNCT03229421
Dermatologic Manifestations of Zika Virus
An observational study of Zika Virus Symptoms and the Associated Exanthema, run by Northwestern University at 1 site in Dominican Republic.
Trial summary
The purpose of this study is to determine whether any diagnostic patterns exist in the symptom presentation of Zika Virus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Zika Virus Symptoms and the Associated Exanthema
- What is being tested?
- Survey
- How many people
- 0 participants
- Where
- 1 siteDominican Republic
- Study dates
- 6 Jul 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults 18 y/o with confirmed zika virus diagnosis
Who may be able to join
- Adults aged 18 years and older presenting with febrile illness and rash
Who cannot join
- Patients aged 17 years or younger
Trial locations and contacts
1 site in 1 country.
Dominican Republic1 site
Pontificia Universidad Catolica Madre y Maestra, Departamento de Medicina
Santo Domingo, Illinois
About this study
Official title: Survey of Symptoms and Dermatologic Characterization Associated With Zika Virus
The purpose of this study is to determine whether any diagnostic patterns exist in the symptom presentation of Zika Virus.
Read the 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.
- Being tested
- Survey
- Keywords
- Zika Virus
- Medical subject headings
- Zika Virus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
18 question symptom assessment tool including non-identifying demographic information questions.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 20 minutes
Secondary outcomes (1)
Frequency measures of initial clinical presentations
Frequency of reported symptoms at initial clinical presentation.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start6 Jul 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Why it stopped: Unable to enroll eligible participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zika Virus Symptoms and the Associated ExanthemaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Pontificia Universidad Catolica Madre y Maestra
- Responsible party
- Principal investigator, Roopal Kundu, Northwestern University
- Investigators
- Roopal V. Kundu, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229421
- Sponsor's protocol ID
- STU00205325
- Acronym
- DMZV
- Status last verified
- Jan 2019
- First submitted
- 18 Jul 2017
- Last updated
- 4 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of Symptoms and Dermatologic Characterization Associated With Zika Virus
- ClinicalTrials.gov ID
- NCT03229421
- Acronym / sponsor ID
- DMZV / STU00205325
- Keywords
- Zika Virus
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to enroll eligible participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Pontificia Universidad Catolica Madre y Maestra
- Study start
- 6 Jul 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 25 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults 18 y/o with confirmed zika virus diagnosis
Key inclusion criteria (1 listed)
- Adults aged 18 years and older presenting with febrile illness and rash
Key exclusion criteria (1 listed)
- Patients aged 17 years or younger
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey18 question symptom assessment tool including non-identifying demographic information questions. | Other | – |
Primary outcome
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
1 secondary outcome
Frequency measures of initial clinical presentations
Time frame: 20 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roopal V. Kundu, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Zika Virus Symptoms and the Associated Exanthema, run by Northwestern University at 1 site in Dominican Republic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days with specific symptoms (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.