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NCT Number: NCT02784743

Impact of Albendazole -Ivermectin on Wuchereria Bancrofti in Mali

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.

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Key information

Conditions

Lymphatic Filariasis Elephantiasis, Filarial Filariasis Helminthiasis Hemic and Lymphatic Diseases Infections Lymphatic Diseases Lymphedema Mosquito-Borne Diseases Nematode Infections Parasitic Diseases Secernentea Infections Spirurida Infections Vector Borne Diseases

Age range

5 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • resident of the 6 villages
  • 5 years and above

Exclusion criteria

  • pregnant women
  • breastfeeding women

Treatment and study plan

''albendazole'' and ''ivermectin''

Drug

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

Other names: Zentel and Mectizan

Primary outcomes

  1. vector infection and infectivity rates

    Time frame: 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 outcomes

  1. Post MDA adverses events related to the drug albendazo and ivermectin

    Time frame: up to 12 months

    after the administration of the drug the investigators assess the reaction to the treatment

  2. impact of albendazole ivermectin treatment on microfilaremia

    Time frame: up to 12 months

    night thick smears on eligible volunteers 5 years and above

Sponsors and collaborators

Lead sponsor

Centre d'Appui à la lutte contre la Maladie

Other

Collaborators

  • Malaria Research and Training Center, Bamako, Mali
  • World Health Organization

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2008
Study completion
2015
First posted
May 27, 2016
Registry last updated
May 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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