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

Scabies Clinical Trial

— GUYAGALE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04931680
• Other study ID #: GUYAGALE
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Scabies

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)