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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04931680
Acronym
GUYAGALE
Enrollment
276
Registered
2021-06-18
Start date
2021-03-29
Completion date
2021-08-25
Last updated
2021-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scabies

Keywords

Scabies, Risk Factors, Prevalence, Indigenous Population

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)

Interventions

OTHERData 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.

Sponsors

Centre Hospitalier de Cayenne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Confirmed or clinical diagnosis of scabiesAt enrollment (D0) - one dayConfirmed or clinical diagnosis of scabies : at enrollment (D0)
Presence of impetigoAt enrollment (D0) - one dayPresence of impetigo : at enrollment (D0)
Presence of proteinuriaSix weeks after enrollment (S6)Presence of proteinuria : six weeks after enrollment (S6)

Other

MeasureTime frameDescription
Qualitative study by semi-structured questionnaireSix weeks after enrollment (S6)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)

Countries

French Guiana

Contacts

Primary ContactPierre COUPPIE, PhD
pierre.couppie@ch-cayenne.fr+594 594 39 53 59
Backup ContactMathieu NACHER, PhD
mathieu.nacher@ch-cayenne.fr+594 594 39 50 24

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026