Impact of Albendazole -Ivermectin on Wuchereria Bancrofti in Mali

Sponsor

Centre d'Appui à la lutte contre la Maladie (Other)

Overall Status

Completed

CT.gov ID

NCT02784743

Collaborator

Malaria Research and Training Center, Bamako, Mali (Other), World Health Organization (Other)

1,139

Enrollment

Arm

167

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphatic Filariasis	Drug: ''albendazole'' and ''ivermectin''	Phase 4

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.

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 Design

Study Type:

Interventional

Actual Enrollment :

1139 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2001

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Drug: ''albendazole'' and ''ivermectin'' annual single dose administration of albendazole 400mg and ivermectin 150ug/kg of weight (according to the height) Other Names: Zentel and Mectizan

Arm

Intervention/Treatment

Experimental: 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).

Drug: ''albendazole'' and ''ivermectin''

annual single dose administration of albendazole 400mg and ivermectin 150ug/kg of weight (according to the height)

Other Names:

Zentel and Mectizan

Outcome Measures

Primary Outcome Measures

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

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