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

NCT04931680 | Unknown

• 1 other identifier: GUYAGALE
• Study Type: observational
• Target: 276
• Locations: 1 country
• Sites: 1

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.

Conditions

Scabies

Keywords

Scabies; Risk Factors; Prevalence; Indigenous Population

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Confirmed or clinical diagnosis of scabies

  At enrollment (D0) - one day

• Presence of impetigo

  At enrollment (D0) - one day

• Presence of proteinuria

  Six weeks after enrollment (S6)

Other Outcomes (1)

• Qualitative study by semi-structured questionnaire

  Six weeks after enrollment (S6)

Study Arms (2)

Patients with treatment success

Patients with diagnosis of "confirmed" or "clinical" scabies and treatment success

Other: Data collection

Patients with treatment failure

Patients with diagnosis of "confirmed" or "clinical" scabies and treatment failure

Other: Data collection

Interventions

Data collection OTHER

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 treatment success

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patient with possible diagnosis of scabies, not fulfilling the criteria for " confirmed " or " clinical " scabies
• Refusal of the questionnaire or the follow-up consultation

Sponsors & Collaborators

• Centre Hospitalier de Cayenne: lead

Study Sites (1)

General Hospital of Cayenne

Cayenne, 97306, French Guiana

RECRUITING

Related 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.

  PMID: 31178154 BACKGROUND

MeSH Terms

Conditions

Scabies

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Mite Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Romain BLAIZOT, MD

  Centre Hospitalier de Cayenne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre COUPPIE, PhD

CONTACT

+594 594 39 53 59; pierre.couppie@ch-cayenne.fr

Mathieu NACHER, PhD

CONTACT

+594 594 39 50 24; mathieu.nacher@ch-cayenne.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: June 18, 2021
• Study Start: March 29, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 25, 2021
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

FR (1)