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

C

Centre Hospitalier de Cayenne

Status

Unknown

Conditions

Scabies

Treatments

Other: Data collection

Study type

Observational

Funder types

Other

Identifiers

NCT04931680
GUYAGALE

Details and patient eligibility

About

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.

Full 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)

Enrollment

276 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

  • 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

Trial design

276 participants in 2 patient groups

Patients with treatment success
Description:
Patients with diagnosis of "confirmed" or "clinical" scabies and treatment success
Treatment:
Other: Data collection
Patients with treatment failure
Description:
Patients with diagnosis of "confirmed" or "clinical" scabies and treatment failure
Treatment:
Other: Data collection

Trial contacts and locations

1

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Central trial contact

Pierre COUPPIE, PhD; Mathieu NACHER, PhD

Data sourced from clinicaltrials.gov

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