An observational study in Scabies, sponsored by Centre Hospitalier de Cayenne. Status unknown at 1 site in French Guiana. Per ClinicalTrials.gov, last updated 2021-06-18.
Sponsored by Centre Hospitalier de Cayenne · Observational
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.
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)
51 studies on the registry are indexed under Scabies; 10 are open to participants now.
This study's planned enrollment of 276 is below the median of 775 across 10 observational studies indexed under Scabies.
Browse Scabies studies →Centre Hospitalier de Cayenne is the lead sponsor of 47 studies on the registry; 9 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Confirmed or clinical scabies according to the criteria of the International Alliance for the Control of Scabies
Patient with possible diagnosis of scabies, not fulfilling the criteria for " confirmed " or " clinical " scabies
Patients with diagnosis of "confirmed" or "clinical" scabies and treatment success
Other: Data collection
Patients with diagnosis of "confirmed" or "clinical" scabies and treatment failure
Other: Data collection
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.
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)
Time frame: Six weeks after enrollment (S6)
Confirmed or clinical diagnosis of scabies
Confirmed or clinical diagnosis of scabies : at enrollment (D0)
Time frame: At enrollment (D0) - one day
Presence of impetigo
Presence of impetigo : at enrollment (D0)
Time frame: At enrollment (D0) - one day
Presence of proteinuria
Presence of proteinuria : six weeks after enrollment (S6)
Time frame: Six weeks after enrollment (S6)
Qualitative study by semi-structured questionnaire
Qualitative study by questionnaire performed by a trained anthropologist to determine the knowledge, attitudes and practices of patients infected with scabies in the study area (S6)
Time frame: Six weeks after enrollment (S6)
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier de Cayenne