Evaluation of the Diagnosis Performances of DEC LTS-2 Skin Patch for Onchocerciasis in Central Africa

Center for Research on Filariasis and Other Tropical Diseases, Cameroon

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Conditions

Onchocerciasis Loiasis Diagnoses Disease Neglected Diseases

Interventions

LTS-2 DEC patchDIAGNOSTIC_TEST

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).

Skin snipsDIAGNOSTIC_TEST

Regarding skin snips, a reading will be done at 24 hours after incubation of the skin in saline serum during 24 hours.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Centre de Recherche sur les filarioses et autres maladies tropicales (CRFilMT)

Yaoundé, Cameroon

Outcomes

Primary Outcomes

Tolerability of the patch

Proportion of individuals having developed a generalized Mazzotti's reaction

Time frame: 24 hours

Feasibility of the patch

Proportion of individuals for whom the patches are spontaneously removed from the skin during the 24 hours.

Time frame: 24 hours

Secondary Outcomes

Diagnosis performances

Assessment of the sensibility, specificity, and predictive values of the LTS-2 DEC patch compared to the results from the skin snips.

Time frame: 24 hours

Loiasis and cross-reactivity assessment

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

Time frame: 24 hours

Semi-quantitative scoring of the LTS-2 DEC patch results

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)

Time frame: 24 hours

Data from ClinicalTrials.gov

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