Current Organisation

Current Job Title

Biography

Project Title

Situation analysis of Ivermectin mass drug administration in the Logon Occidental Region of Chad: Have we reached the point of stopping MDA?

EDCTP Project Call

Senior Fellowship Plus (SFP)

Host Organisation

Project Objectives

This project has four objectives divided into four workpackages WP1. Efficacy assessment of Rifampicin and Albendazole to treat onchocerciasis WP2. Efficacy assessment of Rifampicin and Albendazole to treat onchocerciasis and loiasis co-infected individuals WP3: Capacity to Community engagement, Ethics, Legal and social issues in clinical trials WP4. Capacity building in clinical trials

Study Design

Prospective, randomized, controlled, monocentric, open-label, parallel-group, interventional phase II pilot trial with blinded endpoint evaluation using combination of RIF plus ALB.

Project Summary

Background: The current therapeutic strategy of Onchocerciasis that relies on annual ivermectin mass drug administration (IVM-MDA) has not been very successful in rain forest of Central and West Africa, due to severe adverse events reported on individuals harboring high load of Loa loa microfilariae. Studies carried out in animal models recently demonstrated that elevated exposures to orally-administered rifampicin can lead to Wolbachia depletions from filariae more rapidly than those achieved by doxycycline. In a second study the combination of Rifampicin plus Albendazole given for only 7 days depleted Wolbachia in adult worms drastically, blocked embryogenesis, and stopped microfilariae production. This trial is designed to validate the above pre-clinical observations with a perspective of repurposing the existing drugs for the treatment of onchocerciasis in areas where Ivermectin does not give satisfactory results because of Loa loa. This project will also give opportunity for Community and public engagement and training of scientists in clinical trial in the central African sub-region where there is a great need of clinical trial scientists. SCIENTIFIC AIMS: The main objective is to show efficacy of the combination Rifampicin plus Albendazole, in adult worms using immunohistology and molecular techniques compared to Doxycycline alone or Ivermectin alone DEVELOPMENTAL AIMS: The main developmental aim to be delivered will be the training through research scientists in research methodologies, laboratory skills, clinical trial skills, statistics, research governance and administration from Cameroon STUDY DESIGN: A prospective randomized, Phase II, non-inferiority study of 35mg/kg/d Rifampicin plus 400mg Albendazole for 7 days or 14 days compared to 28 days of doxycycline. PRIMARY ENDPOINT: The primary end point will be the proportions of living female worms with normal vs. interrupted embryogenesis assessed by immunohistology or molecular technique (PCR) after 22 months SECONDARY ENDPOINTS: Proportion of study participants with absence of microfilariae in the skin or blood, assessed 12 and 24 months compared to pre-treatment. IMPACT If treatment proves successful, it will provide a new treatment for onchocerciasis which could help accelerating the elimination of the disease in areas of loiasis co-endemicity using a “test and treat approach”. This project will help consolidating my ability to carry out complex clinical trial research . Through this senior fellowship, scientists from Cameroon and Chad will have opportunities to acquire new skills for field work, molecular biology techniques and participating to the development of drugs against infectious diseases of poverty..