Diagnoses Disease, Loiasis, Neglected Diseases, Onchocerciasis
Conditions
Keywords
Health Public
Brief summary
This study aims at evaluating the diagnosis performances of the LTS-2 DEC patch for onchocerciasis compared to the gold standard which are the skin snips. This study will be conducted in Cameroon in two different areas : Ngog-Mapubi and Bafia Health Districts (one area only endemic for onchocerciasis, and one area endemic for both loiasis and onchocerciasis).
Interventions
DIAGNOSTIC_TESTLTS-2 DEC patch
After 24 hours, the patch will be removed, and then the reaction of the skin under the device will be assessed : no reaction, weak reaction (\< 50% skin surface under the patch), medium reaction (\> 50% skin surface under the patch), and important reaction (reaction on all the surface of the skin under the patch).
DIAGNOSTIC_TESTSkin snips
Regarding skin snips, a reading will be done at 24 hours after incubation of the skin in saline serum during 24 hours.
Sponsors
Center for Research on Filariasis and Other Tropical Diseases, Cameroon
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
Results from LTS-2 patch will be immediately known by both participant and investigators ; but results from skin snips will be masked both for participant and investigators.
Intervention model description
Each participant will have both a LTS-2 patch applied on the skin and a skin snip performed.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* All voluntary adults
Exclusion criteria
* General acute infection (temperature ≥ 38,5°C) * Impaired general condition * Ivermectin taken in the 6 last months * Known allergies to one of the component of the patch * Dermatological acute infection (bacterial, atopic, prurigo, or zona)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of the patch | 24 hours | Proportion of individuals having developed a generalized Mazzotti's reaction |
| Feasibility of the patch | 24 hours | Proportion of individuals for whom the patches are spontaneously removed from the skin during the 24 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis performances | 24 hours | Assessment of the sensibility, specificity, and predictive values of the LTS-2 DEC patch compared to the results from the skin snips. |
| Loiasis and cross-reactivity assessment | 24 hours | Loiasis impact of the diagnosis performances of the LTS-2 DEC patch. Loiasis will be assessed with thick blood smears and a microscopic examination ; and with PCR in the skin snips |
| Semi-quantitative scoring of the LTS-2 DEC patch results | 24 hours | Relationship between the number of microfilariae of O. volvulus and the skin reaction under the patch (0 no reaction, 1: \< 50% of the skin under the patch, 2: \>50% of the skin under the patch, and 3: reaction under all the skin surface of the patch) |
Countries
Cameroon
Outcome results
None listed