Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi (FED)

February 26, 2015 updated by: Neil French, London School of Hygiene and Tropical Medicine

Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi, Open Label Study

Albendazole and ivermectin are currently used in combination for annual mass treatment of lymphatic filariasis in Africa. Although the drugs have been donated, the cost of such programmes is very high and has proven to be a major impediment to the success of programmes in many countries with limited financial resources.

Data from albendazole treatment of other filarial infections and one study comparing single to multi-dose Diethycarbamazine/albendazole in lymphatic filariasis suggest that increased dose and/or frequency of albendazole dosing may be more effective in clearing microfilariae. It is essential to determine whether such higher doses are indeed beneficial since this could have far-reaching effects on the conduct and management of the main mass treatment programmes and also in the management of programmes as they near elimination.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The proposed study will enrol up to 120 volunteers with microfilaremic Wuchereria bancrofti infection who would be randomized to receive standard annual treatment (albendazole 400 mg + ivermectin 200 mcg/kg), annual treatment with an increased dose of albendazole (albendazole 800 mg + ivermectin 200400 mcg/kg) or semi-annual treatment with a standard (albendazole 400 mg + ivermectin 200 mcg/kg), or an increased albendazole dose (albendazole 800 mg + ivermectin 200 400 mcg/kg). Microfilarial levels, as well as measures of adult worm burden (circulating antigen) will be followed every six months for two years to determine whether the higher doses, or more frequent regimens are more effective.

The data obtained would be used, in combination with the data from other similar studies being conducted in Mali and in India to advise the Global Programme for the Elimination of Lymphatic Filariasis (GPELF) on improved methods of treatment both for mass treatment and for the management of problem areas within the global programme.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malawi
      • Karonga, Malawi
        • Karonga Prevention Study

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

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • understand and sign informed consent
  • willing to undergo night blood sampling every 6 months for 2 years
  • Age 18 to 55 years
  • Haemoglobin of equal or above 9g/dl
  • Microfilarial level of equal or above 80mg/dl

Exclusion Criteria:

  • Non- consenting
  • Pregnancy or lactation
  • Treatment with albendazole or ivermectin within the previous 6 months
  • Known allergy to the study drugs

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: albendazole 400mg and ivermectin 200mcg/kg
Annual treatment
Drug: Albendazole 400mg and ivermectin 200mcg/kg
400 mg orally given annually
Drug: Albendazole 400mg and ivermectin 200mcg/kg
Albendazole 400mg and ivermectin 200mcg/kg given twice a year
Active Comparator: Albendazole 800mg and ivermectin 400mcg/kg
Annual treatment
Drug: Albendazole and ivermectin
albendazole 800 mg and ivermectin 400mg orally given annually
Active Comparator: Albendazole 400mg and ivermectin 200mcg/kg
albendazole 400mg and ivermectin 200mcg/kg given twice a year
Drug: Albendazole 400mg and ivermectin 200mcg/kg
400 mg orally given annually
Drug: Albendazole 400mg and ivermectin 200mcg/kg
Albendazole 400mg and ivermectin 200mcg/kg given twice a year
Active Comparator: Albendazole 800mg and ivermectin 400mcg /kg bi-annually
Albendazole 800mg and ivermectin 400mcg/kg given twice a year
Drug: albendazole 800mg and ivermectin 400mcg/kg bi-annually
albendazole 800mg and ivermectin 400mcg/kg given twice a year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Achieving Microfilarial Clearance
Time Frame: 12 months
Microfilaria clearance will be assessed in regard to dosage as well as frequency of treatment. Microfilarial clearance is defined by non-detection of microfilaria in the night blood sample.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Microfilarial Clearance at 24 Months of Follow up
Time Frame: 24 months
Microfilaria will be detected using the nucleopore filtration technique and analysed according to the respective treatment arms at the 24 month time point. Microfilarial clearance will be defined by non-detection of microfilaria in the night blood sample
24 months

Collaborators and Investigators

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

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

Emory University

Investigators

  • Principal Investigator: Neil French, MB ChB PHD, London School of Hygiene and Tropical Medicine

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

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

January 1, 2009

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

September 30, 2010

First Submitted That Met QC Criteria

October 1, 2010

First Posted (Estimate)

October 4, 2010

Study Record Updates

Last Update Posted (Estimate)

February 27, 2015

Last Update Submitted That Met QC Criteria

February 26, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FED-311207

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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