Clincosm LogoSign in Get a demo

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

Sponsor
Seton Healthcare Family (Other)
Overall Status
Completed
CT.gov ID
NCT02254564
Collaborator
(none)
17
Enrollment
5
Locations
37
Actual Duration (Months)
3.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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.

    Study Design

    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 :
    Oct 1, 2014
    Actual Primary Completion Date :
    Aug 1, 2017
    Actual Study Completion Date :
    Oct 31, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Identification of DNA sequences within scabies that can be used to identify the parasite through PCR [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seton Family of Hospitals- Trinity and Hays Clinic Austin Texas United States 78701
    2 University Medical Center Brackenridge and Paul Bass Clinic Austin Texas United States 78701
    3 University of Texas Physicians at Trinity Austin Texas United States 78701
    4 Seton Family of Hospitals- Dell Children's Medical Center of Central Texas and Specially for Children Austin Texas United States 78723
    5 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

    • Principal Investigator: Dayna Diven, MD, Seton Healthcare Family

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dayna Diven, Physician, Seton Healthcare Family
    ClinicalTrials.gov Identifier:
    NCT02254564
    Other Study ID Numbers:
    • Scabies 1
    First Posted:
    Oct 2, 2014
    Last Update Posted:
    Jul 3, 2018
    Last Verified:
    Jun 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Scabies

    Study Results

    No Results Posted as of Jul 3, 2018