ScabiesGUYAGALENCT04931680
Risk Factors for Treatment Failure of Scabies in Autochthonous Populations of French Guiana (GUYAGALE)
An observational study of Scabies, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Scabies
- What is being tested?
- Data collection
- How many people
- 276 participants
- Where
- 1 siteFrench Guiana
- Study dates
- 29 Mar 2021to 25 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patient with possible diagnosis of scabies, not fulfilling the criteria for " confirmed " or " clinical " scabies
- Refusal of the questionnaire or the follow-up consultation
Trial locations and contacts
1 site in 1 country.
French Guiana1 site, 1 recruiting
- Recruiting
General Hospital of Cayenne
Cayenne, 97306
Mathieu NACHER, MD, PhD, +594 594 39 50 24 ext. 5024, mathieu.nacher@ch-cayenne.fr
Pierre COUPPIE, MD,PhD
About this study
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.
Read the 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)
- Conditions
- Scabies
- Being tested
- Data collection
- Keywords
- Scabies, Risk Factors, Prevalence, Indigenous Population
- Medical subject headings
- Scabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with treatment success | Patients with diagnosis of "confirmed" or "clinical" scabies and treatment success Receives: Other: Data collection | |
| Patients with treatment failure | Patients with diagnosis of "confirmed" or "clinical" scabies and treatment failure Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Six weeks after enrollment (S6)
Secondary outcomes (3)
Confirmed or clinical diagnosis of scabies
Confirmed or clinical diagnosis of scabies : at enrollment (D0)
Measured: At enrollment (D0) - one day
Presence of impetigo
Presence of impetigo : at enrollment (D0)
Measured: At enrollment (D0) - one day
Presence of proteinuria
Presence of proteinuria : six weeks after enrollment (S6)
Measured: Six weeks after enrollment (S6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start29 Mar 2021
- Primary completion1 Aug 2021 (estimated)
- Study completion25 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ScabiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cayenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain BLAIZOT, MD, Principal investigator, Centre Hospitalier de Cayenne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931680
- Sponsor's protocol ID
- GUYAGALE
- Acronym
- GUYAGALE
- Status last verified
- Jun 2021
- First submitted
- 11 May 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31178154
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Treatment Failure of Scabies in Autochthonous Populations of French Guiana (GUYAGALE)
- ClinicalTrials.gov ID
- NCT04931680
- Acronym / sponsor ID
- GUYAGALE / GUYAGALE
- Conditions
- Scabies
- Keywords
- Scabies, Risk Factors, Prevalence, Indigenous Population
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Centre Hospitalier de CayenneUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 25 Aug 2021 (estimated)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with treatment success | – | Other: Data collectionPatients with diagnosis of "confirmed" or "clinical" scabies and treatment success |
| Patients with treatment failure | – | Other: Data collectionPatients with diagnosis of "confirmed" or "clinical" scabies and treatment failure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
Key exclusion criteria (2 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionDuring 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. | Other | Patients with treatment failure, Patients with treatment success |
Primary outcome
Number of participants with treatment failure of scabies
Time frame: Six weeks after enrollment (S6)
Number of participants with treatment failure of scabies (persistance of cutaneous lesions), six weeks after enrollment (S6)
3 secondary outcomes
Confirmed or clinical diagnosis of scabies
Time frame: At enrollment (D0) - one day
Presence of impetigo
Time frame: At enrollment (D0) - one day
Presence of proteinuria
Time frame: Six weeks after enrollment (S6)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Background: PubMed 31178154Engelman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romain BLAIZOT, MD principal investigator
Centre Hospitalier de Cayenne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scabies, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in French Guiana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre COUPPIE, PhD (+594 594 39 53 59, pierre.couppie@ch-cayenne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment failure of scabies (time frame: Six weeks after enrollment (S6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04931680, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.