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

Scabies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02254564
• Other study ID #: Scabies 1
• Status: Completed
• Start date: October 2014
• Est. completion date: October 31, 2017

Study information

• Verified date: June 2018
• Source: Seton Healthcare Family
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 31, 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Scabies

Locations

Country	Name	City	State
United States	Seton Family of Hospitals- Dell Children's Medical Center of Central Texas and Specially for Children	Austin	Texas
United States	Seton Family of Hospitals- Trinity and Hays Clinic	Austin	Texas
United States	University Medical Center Brackenridge and Paul Bass Clinic	Austin	Texas
United States	University of Texas Physicians at Trinity	Austin	Texas
United States	Seton Family of Hospitals- Seton Luling Family Medicine Clinic and Lockhart Specialty Clinic	Lockhart	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Seton Healthcare Family

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of DNA sequences within scabies that can be used to identify the parasite through PCR		1 year