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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04931680
Other study ID # GUYAGALE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 29, 2021
Est. completion date August 25, 2021

Study information

Verified date June 2021
Source Centre Hospitalier de Cayenne
Contact Pierre COUPPIE, PhD
Phone +594 594 39 53 59
Email pierre.couppie@ch-cayenne.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 276
Est. completion date August 25, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
French Guiana General Hospital of Cayenne Cayenne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier de Cayenne

Country where clinical trial is conducted

French Guiana, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Qualitative study by semi-structured questionnaire 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) Six weeks after enrollment (S6)
Primary Number of participants with treatment failure of scabies Number of participants with treatment failure of scabies (persistance of cutaneous lesions), six weeks after enrollment (S6) Six weeks after enrollment (S6)
Secondary Confirmed or clinical diagnosis of scabies Confirmed or clinical diagnosis of scabies : at enrollment (D0) At enrollment (D0) - one day
Secondary Presence of impetigo Presence of impetigo : at enrollment (D0) At enrollment (D0) - one day
Secondary Presence of proteinuria Presence of proteinuria : six weeks after enrollment (S6) Six weeks after enrollment (S6)
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