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PCR (Polymerase Chain Reaction) Assay for Diagnosis of Sarcoptes Scabiei

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: NCT02254564
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Dayna Diven, Seton Healthcare Family

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.

Condition or disease
Scabies

Detailed Description:
The main objective of this proposed study is to identify unique DNA sequences within the genome of human scabies that can be utilized to identify the parasite through polymerase chain reaction or PCR. The goal of the project is to design an assay that can distinguish samples from skin scrapings containing scabies mites, eggs, or fecal material confirmed by clinic based microscopic evaluation (gold standard) from negative controls (i.e. scrapings for tinea and/or demodex folliculitis) that do not contain Sarcoptes scabiei. We hypothesize that specifically amplifying the unique regions of the Scabies genome using PCR can serve as a means to diagnosis infestations in humans. To address this question, we will optimize PCR amplification of known scabies samples then apply our procedure to DNA extracted from patient samples.

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Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: PCR (Polymerase Chain Reaction) Assay for Diagnosis of Sarcoptes Scabiei
Actual Study Start Date : October 2014
Actual Primary Completion Date : August 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scabies

Group/Cohort
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.



Primary Outcome Measures :
  1. Identification of DNA sequences within scabies that can be used to identify the parasite through PCR [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
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.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients will be recruited upon identifying of scabies by microscopy or when a scraping is performed for suspected tinea or demodex folliculitis
Criteria

Inclusion Criteria:

  • 1. 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

Exclusion Criteria:

  • 1. 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.

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): NCT02254564


Locations
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United States, Texas
Seton Family of Hospitals- Trinity and Hays Clinic
Austin, Texas, United States, 78701
University Medical Center Brackenridge and Paul Bass Clinic
Austin, Texas, United States, 78701
University of Texas Physicians at Trinity
Austin, Texas, United States, 78701
Seton Family of Hospitals- Dell Children's Medical Center of Central Texas and Specially for Children
Austin, Texas, United States, 78723
Seton Family of Hospitals- Seton Luling Family Medicine Clinic and Lockhart Specialty Clinic
Lockhart, Texas, United States, 78644
Sponsors and Collaborators
Seton Healthcare Family
Investigators
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Principal Investigator: Dayna Diven, MD Seton Healthcare Family

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Responsible Party: Dayna Diven, Physician, Seton Healthcare Family
ClinicalTrials.gov Identifier: NCT02254564    
Other Study ID Numbers: Scabies 1
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Scabies
Mite Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases