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

Conditions
Scabies
Interventions
Other: Data collection
Registration Number
NCT04931680
Lead Sponsor
Centre Hospitalier de Cayenne
Brief Summary

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

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)

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
276
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Patients with treatment failureData collectionPatients with diagnosis of "confirmed" or "clinical" scabies and treatment failure
Patients with treatment successData collectionPatients with diagnosis of "confirmed" or "clinical" scabies and treatment success
Primary Outcome Measures
NameTimeMethod
Number of participants with treatment failure of scabiesSix weeks after enrollment (S6)

Number of participants with treatment failure of scabies (persistance of cutaneous lesions), six weeks after enrollment (S6)

Secondary Outcome Measures
NameTimeMethod
Presence of impetigoAt enrollment (D0) - one day

Presence of impetigo : at enrollment (D0)

Presence of proteinuriaSix weeks after enrollment (S6)

Presence of proteinuria : six weeks after enrollment (S6)

Confirmed or clinical diagnosis of scabiesAt enrollment (D0) - one day

Confirmed or clinical diagnosis of scabies : at enrollment (D0)

Trial Locations

Locations (1)

General Hospital of Cayenne

🇬🇫

Cayenne, French Guiana

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