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

NCT ID: NCT04931680

Last Updated: 2021-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

276 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-29

Study Completion Date

2021-08-25

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)

Conditions

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Scabies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with treatment success

Patients with diagnosis of "confirmed" or "clinical" scabies and treatment success

Data collection

Intervention Type OTHER

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.

Patients with treatment failure

Patients with diagnosis of "confirmed" or "clinical" scabies and treatment failure

Data collection

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier de Cayenne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Romain BLAIZOT, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de Cayenne

Locations

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General Hospital of Cayenne

Cayenne, , French Guiana

Site Status RECRUITING

Countries

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French Guiana

Central Contacts

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Pierre COUPPIE, PhD

Role: CONTACT

+594 594 39 53 59

Mathieu NACHER, PhD

Role: CONTACT

+594 594 39 50 24

Facility Contacts

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Mathieu NACHER, MD, PhD

Role: primary

+594 594 39 50 24 ext. 5024

References

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Engelman D, Cantey PT, Marks M, Solomon AW, Chang AY, Chosidow O, Enbiale W, Engels D, Hay RJ, Hendrickx D, Hotez PJ, Kaldor JM, Kama M, Mackenzie CD, McCarthy JS, Martin DL, Mengistu B, Maurer T, Negussu N, Romani L, Sokana O, Whitfeld MJ, Fuller LC, Steer AC. The public health control of scabies: priorities for research and action. Lancet. 2019 Jul 6;394(10192):81-92. doi: 10.1016/S0140-6736(19)31136-5. Epub 2019 Jun 6.

Reference Type BACKGROUND
PMID: 31178154 (View on PubMed)

Other Identifiers

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GUYAGALE

Identifier Type: -

Identifier Source: org_study_id

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