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

Diagnoses Disease Clinical Trial

— EOLoa  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04035174
• Other study ID #: C18-56
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: November 2021
• Source: Center for Research on Filariasis and Other Tropical Diseases, Cameroon
• Contact: Cédric B Chesnais, MD
• Phone: +33467416162
• Email: cedric.chesnais[@]ird.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1400
• Est. completion date: March 30, 2023
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diagnoses Disease
• Loiasis
• Neglected Diseases
• Onchocerciasis

Intervention

Diagnostic Test:
• LTS-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).
• Skin snips
Regarding skin snips, a reading will be done at 24 hours after incubation of the skin in saline serum during 24 hours.

Locations

Country	Name	City	State
Cameroon	Centre de Recherche sur les filarioses et autres maladies tropicales (CRFilMT)	Yaoundé

Sponsors (1)

Lead Sponsor	Collaborator
Center for Research on Filariasis and Other Tropical Diseases, Cameroon

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability of the patch	Proportion of individuals having developed a generalized Mazzotti's reaction	24 hours
Primary	Feasibility of the patch	Proportion of individuals for whom the patches are spontaneously removed from the skin during the 24 hours.	24 hours
Secondary	Diagnosis performances	Assessment of the sensibility, specificity, and predictive values of the LTS-2 DEC patch compared to the results from the skin snips.	24 hours
Secondary	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	24 hours
Secondary	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)	24 hours