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

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.

Study Overview

• Status: Recruiting
• Conditions: Scabies
• Intervention / Treatment: Other: Data collection

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)

• Study Type: Observational
• Enrollment (Anticipated): 276

Contacts and Locations

• Study Contact: Name: Pierre COUPPIE, PhD; Phone Number: +594 594 39 53 59; Email: pierre.couppie@ch-cayenne.fr
• Study Contact Backup: Name: Mathieu NACHER, PhD; Phone Number: +594 594 39 50 24; Email: mathieu.nacher@ch-cayenne.fr

Study Locations

• French Guiana
  • Cayenne, French Guiana, 97306
    • Recruiting
    • General Hospital of Cayenne
    • Contact: Mathieu Nacher, MD, PhD; Phone Number: 5024 +594 594 39 50 24; Email: mathieu.nacher@ch-cayenne.fr
    • Principal Investigator: Pierre COUPPIE, MD,PhD
    • Sub-Investigator: Romain BLAIZOT, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

• 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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with treatment success; Patients with diagnosis of "confirmed" or "clinical" scabies and treatment success	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.
Patients with treatment failure; Patients with diagnosis of "confirmed" or "clinical" scabies and treatment failure	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmed or clinical diagnosis of scabies	Confirmed or clinical diagnosis of scabies : at enrollment (D0)	At enrollment (D0) - one day
Presence of impetigo	Presence of impetigo : at enrollment (D0)	At enrollment (D0) - one day
Presence of proteinuria	Presence of proteinuria : six weeks after enrollment (S6)	Six weeks after enrollment (S6)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Cayenne
• Investigators: Principal Investigator: Romain BLAIZOT, MD, Centre Hospitalier de Cayenne

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): August 25, 2021

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: June 11, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 11, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Prevalence; Risk Factors; Scabies; Indigenous Population
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Parasitic Diseases; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Mite Infestations; Scabies
• Other Study ID Numbers: GUYAGALE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No