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In this cross-sectional diagnostic study, healthy adults aged 18 and older with suspected, clinical, or confirmed scabies will be recruited. The objective is to determine if the sensitivity of self-collected skin samples for scabies diagnosis is non-inferior to professional sampling, and compare the sensitivity and specificity of the polymerase chain reaction assay (PCR) versus microscopy.
Scabies infestations have significantly increased globally in the last 10-20 years, including a threefold rise in the Netherlands over the past decade. Diagnosing scabies is challenging due to varied symptoms and low sensitivity of current microscopic methods. New diagnostic techniques like PCR, which offer higher sensitivity, are being investigated. The feasibility of self-collected skin samples is being explored to reduce the burden on healthcare services and address issues like autonomy, stigma, and privacy.
In this cross-sectional diagnostic study, healthy adults aged 18 and older with suspected, clinical, or confirmed scabies will be included. Primary endpoint is the sensitivity of self-collected versus professional skin samples for diagnosing scabies. Secondary endpoints include sensitivity of skin scrapings and swabs, and the sensitivity and specificity of PCR versus microscopy.
Participants will self-collect skin samples during a standard care visit. The process may be slightly sensitive but not painful. There are no direct benefits beyond standard care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | All participants will be asked to perform self-sampling and irrespective of the result will receive current standard-of-care from their health care provider for their suspected scabies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin sampling | Diagnostic Test | All individuals will self-collect skin samples and swabs and fill in a questionnaire. Subsequently, all individuals will see a professional. The professional will collect skin samples and swabs as well. |
| Measure | Description | Time Frame |
|---|---|---|
| The sensitivity of self-collected skin samples for diagnosing scabies | The proportion of self-collected samples collected at the enrolment visit that are tested positive, divided by the total number of participants adjudged retrospectively to have had scabies at their enrolment visit, based on a composite clinical diagnosis. | through study completion, an average of one year |
| The sensitivity of professionally-collected skin samples for diagnosing scabies | The proportion of professionally-collected samples collected at the enrolment visit that are tested positive, divided by the total number of participants adjudged retrospectively to have had scabies at their enrolment visit, based on a composite clinical diagnosis. | through study completion, an average of one year |
| Measure | Description | Time Frame |
|---|---|---|
| The sensitivity of skin scrapings for diagnosing scabies | The proportion of skin scrapings at their enrolment visit (whether professionally or self-collected) that are tested positive by PCR, divided by the total number of participants adjudged retrospectively to have had scabies at baseline, based on a composite clinical diagnosis. | through study completion, an average of one year |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants whose self-sampling location is judged appropriate | Assessed by a professional at T=0 [adequate/non-adequate] | through study completion, an average of one year |
| Motivation for self-collection of skin samples for scabies diagnostics |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew MC McCall, PhD | Contact | 024 361 1111 | +31 | matthew.mccall@radboudumc.nl |
| Saskia C van der Boor, PhD | Contact | 024 361 1111 | +31 | saskia.vanderboor@radboudumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Recruiting | Nijmegen | Gelderland | 6525GA | Netherlands |
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| ID | Term |
|---|---|
| D012532 | Scabies |
| ID | Term |
|---|---|
| D008924 | Mite Infestations |
| D004478 | Ectoparasitic Infestations |
| D012876 | Skin Diseases, Parasitic |
| D010272 | Parasitic Diseases |
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The study design is cross-sectional in terms of the diagnostic process, which aims to determine the presence of scabies in an individual at a specific point in time. All participants will undergo the same diagnostic procedures.
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| The sensitivity of skin swabs for diagnosing scabies | The proportion of skin swabs at their enrolment visit (whether professionally or self-collected) that are tested positive by PCR, divided by the total number of participants adjudged retrospectively to have had scabies at baseline, based on a composite clinical diagnosis. | through study completion, an average of one year |
| The sensitivity and specificity of PCR on skin scraping for diagnosing active scabies infection | The proportion of participants adjudged to have had scabies at their enrolment visit (based on a retrospective composite clinical diagnosis), whose skin scraping at their enrolment visit (whether professionally or self-collected) are tested positive for scabies by PCR, and the proportion of participants adjudged retrospectively to have not had scabies at their enrolment visit whose skin scrapings are tested negative for scabies by PCR. | through study completion |
| The sensitivity and specificity of microscopy on skin scraping for diagnosing active scabies infection | The proportion of participants adjudged to have had scabies at their enrolment visit (based on a retrospective composite clinical diagnosis), whose skin scraping at their enrolment visit (whether professionally or self-collected) are tested positive for scabies by microscopy, and the proportion of participants adjudged retrospectively to have not had scabies at their enrolment visit whose skin scrapings are tested negative* for scabies by microscopy. | through study completion, an average of one year |
Motivation is assessed by items on the questionnaire related to the motivation for self-collection of skin samples for scabies diagnostics, along with the associated facilitators and barriers. |
| through study completion, an average of one year |
| Demographic, clinical and epidemiological factors which influence the sensitivity of self-collected skin samples for scabies diagnosis. | Age, gender, highest level of education, signs/symptoms, living situation, skin color. source of transmission and transmission mode. | through study completion, an average of one year |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |