Risk Factors for Treatment Failure of Scabies in Autochthonous Populations of French Guiana (GUYAGALE)
NCT ID: NCT04931680
Last Updated: 2021-06-18
Study Results
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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UNKNOWN
276 participants
OBSERVATIONAL
2021-03-29
2021-08-25
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with treatment success
Patients with diagnosis of "confirmed" or "clinical" scabies and treatment success
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.
Patients with treatment failure
Patients with diagnosis of "confirmed" or "clinical" scabies and treatment failure
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Agreement to answer to the follow-up questionnaire
* Agreement to come back for a six-weeks follow-up consultation.
Exclusion Criteria
* Refusal of the questionnaire or the follow-up consultation
ALL
No
Sponsors
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Centre Hospitalier de Cayenne
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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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.
Other Identifiers
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GUYAGALE
Identifier Type: -
Identifier Source: org_study_id
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