Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi (FED)
Primary Purpose
Lymphatic Filariasis
Status
Terminated
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
Albendazole 400mg and ivermectin 200mcg/kg
Albendazole and ivermectin
Albendazole 400mg and ivermectin 200mcg/kg
albendazole 800mg and ivermectin 400mcg/kg bi-annually
Sponsored by
About this trial
This is an interventional treatment trial for Lymphatic Filariasis focused on measuring Lymphatic filariasis, microfilaria, Albendazole, ivermectin, human immunodeficiency
Eligibility Criteria
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
Sites / Locations
- Karonga Prevention Study
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
albendazole 400mg and ivermectin 200mcg/kg
Albendazole 800mg and ivermectin 400mcg/kg
Albendazole 400mg and ivermectin 200mcg/kg
Albendazole 800mg and ivermectin 400mcg /kg bi-annually
Arm Description
Annual treatment
Annual treatment
albendazole 400mg and ivermectin 200mcg/kg given twice a year
Albendazole 800mg and ivermectin 400mcg/kg given twice a year
Outcomes
Primary Outcome Measures
Number of Participants Achieving Microfilarial Clearance
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.
Secondary Outcome Measures
Number of Participants With Microfilarial Clearance at 24 Months of Follow up
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
Full Information
NCT ID
NCT01213576
First Posted
September 30, 2010
Last Updated
February 26, 2015
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Emory University
1. Study Identification
Unique Protocol Identification Number
NCT01213576
Brief Title
Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi
Acronym
FED
Official Title
Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi, Open Label Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
Introduction of National Mass Drug Administration Campaign and failure to identify appropriate participants.
Study Start Date
January 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Emory University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphatic Filariasis
Keywords
Lymphatic filariasis, microfilaria, Albendazole, ivermectin, human immunodeficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
albendazole 400mg and ivermectin 200mcg/kg
Arm Type
Active Comparator
Arm Description
Annual treatment
Arm Title
Albendazole 800mg and ivermectin 400mcg/kg
Arm Type
Active Comparator
Arm Description
Annual treatment
Arm Title
Albendazole 400mg and ivermectin 200mcg/kg
Arm Type
Active Comparator
Arm Description
albendazole 400mg and ivermectin 200mcg/kg given twice a year
Arm Title
Albendazole 800mg and ivermectin 400mcg /kg bi-annually
Arm Type
Active Comparator
Arm Description
Albendazole 800mg and ivermectin 400mcg/kg given twice a year
Intervention Type
Drug
Intervention Name(s)
Albendazole 400mg and ivermectin 200mcg/kg
Intervention Description
400 mg orally given annually
Intervention Type
Drug
Intervention Name(s)
Albendazole and ivermectin
Intervention Description
albendazole 800 mg and ivermectin 400mg orally given annually
Intervention Type
Drug
Intervention Name(s)
Albendazole 400mg and ivermectin 200mcg/kg
Intervention Description
Albendazole 400mg and ivermectin 200mcg/kg given twice a year
Intervention Type
Drug
Intervention Name(s)
albendazole 800mg and ivermectin 400mcg/kg bi-annually
Intervention Description
albendazole 800mg and ivermectin 400mcg/kg given twice a year
Primary Outcome Measure Information:
Title
Number of Participants Achieving Microfilarial Clearance
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of Participants With Microfilarial Clearance at 24 Months of Follow up
Description
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
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil French, MB ChB PHD
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karonga Prevention Study
City
Karonga
Country
Malawi
12. IPD Sharing Statement
Citations:
PubMed Identifier
25877874
Citation
Tafatatha TT, Ngwira BM, Taegtmeyer M, Phiri AJ, Wilson TP, Banda LG, Piston WN, Koole O, Horton J, French N. Randomised controlled clinical trial of increased dose and frequency of albendazole and ivermectin on Wuchereria bancrofti microfilarial clearance in northern Malawi. Trans R Soc Trop Med Hyg. 2015 Jun;109(6):393-9. doi: 10.1093/trstmh/trv027. Epub 2015 Apr 15.
Results Reference
derived
Learn more about this trial
Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi
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