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Completed

NCT Number: NCT02254564

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

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.

Completed

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Seton Family of Hospitals- Dell Children's Medical Center of Central Texas and Specially for Children, Austin, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Seton Healthcare Family

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 2, 2014
Registry last updated
Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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