PCR (Polymerase Chain Reaction) Assay for Diagnosis of Sarcoptes Scabiei
1 other identifier
observational
17
1 country
5
Brief Summary
The main objective of this study is to identify unique DNA sequences within the genome of human scabies that can be utilized to identify the parasite through PCR.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2014
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedFirst Posted
Study publicly available on registry
October 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2017
CompletedJuly 3, 2018
June 1, 2018
2.8 years
September 29, 2014
June 29, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Identification of DNA sequences within scabies that can be used to identify the parasite through PCR
1 year
Study Arms (2)
Positive Scrapings
Skin scrapings that are positive for scabies
Negative Controls
collect negative controls from patients in whom tinea (superficial fungal infection) was clinically suspected. Samples from patients with demodex folliculitis (a mite that is commonly found in oil glands on the face) are also intended to be used as negative controls as well.
Eligibility Criteria
Patients will be recruited upon identifying of scabies by microscopy or when a scraping is performed for suspected tinea or demodex folliculitis
You may qualify if:
- \. Male/Female of all ages whose standard clinical treatment produces one or more of the following:
- Slides from skin scrapings containing scabies mites, eggs, and/or fecal material
- Slides from skin scrapings of suspected tinea
- Slides from skin scrapings of demodex mites
You may not qualify if:
- \. Patients who are clinically concerning for having both scabies and tinea/demodex folliculitis to avoid contamination of positive and negative controls in the same sample. Subjects or guardians who cannot understand and read English and so are unable to consent to participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Seton Family of Hospitals- Trinity and Hays Clinic
Austin, Texas, 78701, United States
University Medical Center Brackenridge and Paul Bass Clinic
Austin, Texas, 78701, United States
University of Texas Physicians at Trinity
Austin, Texas, 78701, United States
Seton Family of Hospitals- Dell Children's Medical Center of Central Texas and Specially for Children
Austin, Texas, 78723, United States
Seton Family of Hospitals- Seton Luling Family Medicine Clinic and Lockhart Specialty Clinic
Lockhart, Texas, 78644, United States
Biospecimen
Superficial skin scrapings scales that are collected on microscope slides, which are used to determine diagnosis in clinical settings. After clinicians view the slide under the microscope, the slide is then discarded.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dayna Diven, MD
Seton Healthcare Family
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician
Study Record Dates
First Submitted
September 29, 2014
First Posted
October 2, 2014
Study Start
October 1, 2014
Primary Completion
August 1, 2017
Study Completion
October 31, 2017
Last Updated
July 3, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share