Impact of Albendazole -Ivermectin on Wuchereria Bancrofti in Mali

May 24, 2016 updated by: Centre d'Appui à la lutte contre la Maladie

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1139

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 63 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • resident of the 6 villages
  • 5 years and above

Exclusion Criteria:

  • pregnant women
  • breastfeeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 12 months
impact of albendazole ivermectin treatment on microfilaremia
Time Frame: up to 12 months
night thick smears on eligible volunteers 5 years and above
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre d'Appui à la lutte contre la Maladie

Collaborators

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

Investigators

  • Principal Investigator: Sékou F Traoré, PhD, Malaria Research and Training Center, Mali

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2001

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

April 29, 2015

First Submitted That Met QC Criteria

May 24, 2016

First Posted (Estimate)

May 27, 2016

Study Record Updates

Last Update Posted (Estimate)

May 27, 2016

Last Update Submitted That Met QC Criteria

May 24, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMS/TDR ID# A00563

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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