Impact of Albendazole -Ivermectin on Wuchereria Bancrofti in Mali

Phase 4

Completed

• Conditions: Lymphatic Filariasis
• Interventions: Drug: ''albendazole'' and ''ivermectin''

• Registration Number: NCT02784743
• Lead Sponsor: Centre d'Appui à la lutte contre la Maladie

Brief Summary

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

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).

Study Timeline

• Study Start: 2001-05
• Primary Completion: 2008-12
• Study Completion: 2015-04
• Study First Submitted: 2015-04-29
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-24
• Last Update Submitted: 2016-05-24
• Study First Posted: 2016-05-27
• Last Update Posted: 2016-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1139

Inclusion Criteria

• resident of the 6 villages
• 5 years and above

Exclusion Criteria

• pregnant women
• breastfeeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
albendazole and ivermectin	''albendazole'' and ''ivermectin''	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).

Primary Outcome Measures

Name	Time	Method
vector infection and infectivity rates	up to 7 months	vectors are collected with human landing catch technique and the presence of Wb larvae stage s assessed using dissection method

Secondary Outcome Measures

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