Clinical trial NCT04931680: Risk Factors for Treatment Failure of Scabies in Autochthonous Populations of French Guiana (GUYAGALE)
Official title: Risk Factors for Treatment Failure of Scabies in Autochthonous Populations of French Guiana (GUYAGALE)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Scabies
Keywords: Scabies
Risk Factors
Prevalence
Indigenous Population
Lead sponsor: Centre Hospitalier de Cayenne
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 276
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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)

Eligibility criteria: * 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

Primary outcomes:
measure: Number of participants with treatment failure of scabies
timeFrame: Six weeks after enrollment (S6)
Secondary outcomes:
measure: Confirmed or clinical diagnosis of scabies
timeFrame: At enrollment (D0) - one day
measure: Presence of impetigo
timeFrame: At enrollment (D0) - one day
measure: Presence of proteinuria
timeFrame: Six weeks after enrollment (S6)
Other outcomes:
measure: Qualitative study by semi-structured questionnaire
timeFrame: Six weeks after enrollment (S6)
Locations:
city: Cayenne
country: French Guiana
facility: General Hospital of Cayenne
Study officials:
affiliation: Centre Hospitalier de Cayenne
name: Romain BLAIZOT, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.