Impact of Albendazole -Ivermectin on Wuchereria Bancrofti in Mali

Study Overview
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Brief Summary
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Lymphatic filariasis is a public health problem in Mali. The existing data are not up to date and most of them are more than 15 years old. To address this issue in April 2000, the investigators started studies to update the epidemiology of lymphatic filariasis. There is no ongoing lymphatic filariasis control program in 2000 in Mali in terms of preventive chemotherapy treatment or vector control. To fill these gaps, this current study aims to assess the impact of albendazole-ivermectin combination treatment on Wuchereria bancrofti infection and transmission in 6 rural highly endemic villages of Mali.

Detailed Description
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Lymphatic filariasis is a public health problem in Mali. The existing data are not up to date and most of them are more than 15 years old. To address this issue in April 2000, the investigators started studies to update the epidemiology of lymphatic filariasis. As a result, in two rural areas (Banambani and Sirakoro) located at about 25 km North-East Bamako, the parasite prevalence using ICT cards in August 2000 were 16% (n=150) and 15.0% (n=113) respectively in Banambani and Sirakoro. There is no ongoing lymphatic filariasis control program in 2000 in Mali in terms of preventive chemotherapy treatment or vector control. To fill these gaps, this current study aims to assess the impact of albendazole-ivermectin combination treatment on Wuchereria bancrofti infection and transmission in 6 rural highly endemic villages of Mali. The study will be conducted in three phases: the pre treatment assessment of lymphatic filariasis infection and transmission parameters, treatment phase with annual single dose of albendazole and ivermectin and the post treatment assessment of Anopheles gambiae s.l mosquitoes, the transmission parameters of the vectors in the community, human infection prevalence post treatment using Giemsa -stained thick smears and others test like the Immuno chromatographic test (ICT).

Official Title
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Impact of Albendazole -Ivermectin Combination Treatment on Wuchereria Bancrofti Infection and Transmission in Mali

Conditions
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Lymphatic Filariasis

Intervention / Treatment
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* Drug: ''albendazole'' and ''ivermectin''


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: resident of the 6 villages 5 years and above Exclusion Criteria: pregnant women breastfeeding women

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: albendazole and ivermectin<br>Before and after design with all eligible volunteers receiving the study drugs. Administration of a yearly unique dose of albendazole 400mg and ivermectin 150ug/kg weight ( according to the height). | Drug: ''albendazole'' and ''ivermectin''<br>* annual single dose administration of albendazole 400mg and ivermectin 150ug/kg of weight (according to the height)<br>* Other names: Zentel and Mectizan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vector infection and infectivity rates | vectors are collected with human landing catch technique and the presence of Wb larvae stage s assessed using dissection method | up to 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post MDA adverses events related to the drug albendazo and ivermectin | after the administration of the drug the investigators assess the reaction to the treatment | up to 12 months | 
| impact of albendazole ivermectin treatment on microfilaremia | night thick smears on eligible volunteers 5 years and above | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDA, Wuchereria bancrofti, Anopheles, Albendazole, Ivermectin