Risk Factors for Treatment Failure of Scabies in Autochthonous Populations of French Guiana (GUYAGALE)

Study Overview
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Brief Summary
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Scabies is a Neglected Tropical Disease, particularly important in autochthonous populations. Treatment failures could explain the high prevalence of this disease in Amerindian and Maroon populations of French Guiana. Our main objective is to look for specific sociodemographic risk factors for treatment failure of scabies in the remote areas of French Guiana. A secondary objective is to evaluate the prevalence of scabies and its complications.

Detailed Description
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Scabies is known to be a health issue of particular importance in marginal and autochthonous populations throughout the world. French Guiana is a French territory harbouring several autochthonous populations living in remote rainforest areas. The prevalence of scabies remains high in these areas despite primary care offered by the local health centres. A prevalence of 2.5% was found in two Amerindian villages in a retrospective study in 2019. Therapeutic failures are known to be one of the main causes of a long-lasting high prevalence. In low-resources populations, socio-economic factors and promiscuity are particularly incriminated. The role played by these factors should be studied in French Guiana. Secondary complications such as impetigo and post-streptococcal glomerulonephritis should be evaluated, as they represent an important part of the global burden of scabies. This study will be conducted from April to August 2021 in remote settlements of French Guiana. Patients will be seen during a first inclusion consultation, realized by the same investigator (RB). All patients with diagnosis of  confirmed  or  clinical  scabies according to the International Alliance for the Control of Scabies will be included in case of agreement. Patients will be treated according to the current protocol in the Health Centres for Remote Areas of French Guiana (according to the European guidelines for the treatment of scabies: two doses of ivermectin 0.2mg/kg on day 1 and day 7 ; benzyl benzoate 10% or permethrin 5% for children under 15kg or pregnant women). The follow-up consultation will take place six weeks later. The same investigator (RB) will assess treatment failure or success. Research of etiologic factors associated with treatment failure; multicentric regional sample Category 3 Non-Interventional Human Person Research (RIPH 3)

Official Title
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Risk Factors for Treatment Failure of Scabies in Autochthonous Populations of French Guiana (GUYAGALE)

Conditions
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Scabies

Intervention / Treatment
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* Other: Data collection


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : Confirmed or clinical scabies according to the criteria of the International Alliance for the Control of Scabies Agreement to answer to the follow-up questionnaire Agreement to come back for a six-weeks follow-up consultation. Exclusion criteria: Patient with possible diagnosis of scabies, not fulfilling the criteria for  confirmed  or  clinical  scabies Refusal of the questionnaire or the follow-up consultation
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with treatment success<br>Patients with diagnosis of confirmed or clinical scabies and treatment success | Other: Data collection<br>* During the follow-up consultation, six weeks after inclusion (S6), data will be collected using a standardized digital questionnaire, including clinical features, economic, social and cultural characteristics, housing conditions and therapeutic details (type of environmental decontamination and treatment received). Data will then be compared between patients with therapeutic success or failure. A urine test strip will also be used during the S6 consultation to screen for proteinuria. The prevalence of post-streptococcal glomerulonephritis will be extrapolated from that of proteinuria.<br>|
| Patients with treatment failure<br>Patients with diagnosis of confirmed or clinical scabies and treatment failure | Other: Data collection<br>* During the follow-up consultation, six weeks after inclusion (S6), data will be collected using a standardized digital questionnaire, including clinical features, economic, social and cultural characteristics, housing conditions and therapeutic details (type of environmental decontamination and treatment received). Data will then be compared between patients with therapeutic success or failure. A urine test strip will also be used during the S6 consultation to screen for proteinuria. The prevalence of post-streptococcal glomerulonephritis will be extrapolated from that of proteinuria.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment failure of scabies | Number of participants with treatment failure of scabies (persistance of cutaneous lesions), six weeks after enrollment (S6) | Six weeks after enrollment (S6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmed or clinical diagnosis of scabies | Confirmed or clinical diagnosis of scabies : at enrollment (D0) | At enrollment (D0) - one day | 
| Presence of impetigo | Presence of impetigo : at enrollment (D0) | At enrollment (D0) - one day | 
| Presence of proteinuria | Presence of proteinuria : six weeks after enrollment (S6) | Six weeks after enrollment (S6) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scabies, Risk Factors, Prevalence, Indigenous Population