Clinical trial NCT02254564: PCR (Polymerase Chain Reaction) Assay for Diagnosis of Sarcoptes Scabiei
Official title: PCR (Polymerase Chain Reaction) Assay for Diagnosis of Sarcoptes Scabiei
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scabies
Lead sponsor: Seton Healthcare Family
Sponsor class: OTHER
First posted: 2014-10-02
Enrollment: 17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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.

Primary outcomes:
measure: Identification of DNA sequences within scabies that can be used to identify the parasite through PCR
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Seton Family of Hospitals- Trinity and Hays Clinic
state: Texas
city: Austin
country: United States
facility: University Medical Center Brackenridge and Paul Bass Clinic
state: Texas
city: Austin
country: United States
facility: University of Texas Physicians at Trinity
state: Texas
city: Austin
country: United States
facility: Seton Family of Hospitals- Dell Children's Medical Center of Central Texas and Specially for Children
state: Texas
city: Lockhart
country: United States
facility: Seton Family of Hospitals- Seton Luling Family Medicine Clinic and Lockhart Specialty Clinic
state: Texas
Study officials:
affiliation: Seton Healthcare Family
name: Dayna Diven, MD
role: PRINCIPAL_INVESTIGATOR
References: