Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi (FED)
Recruitment status was Active, not recruiting
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Purpose
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 DEC/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.
| Condition | Intervention |
|---|---|
|
Lymphatic Filariasis |
Drug: Albendazole 400mg and ivermectin 200mcg/kg Drug: Albendazole and ivermectin Drug: albendazole 800mg and ivermectin 400mcg/kg bi-annually |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi, Open Label Study |
- Microfilarial clearance [ Time Frame: 12 months ] [ Designated as safety issue: No ]Microfilaria clearance will be assessed in regard to dosage as well as frequency of treatment
- Assess effect of study treatment on microfilaria intensity after 2 years of follow-up [ Time Frame: 24 months ] [ Designated as safety issue: No ]Number of microfilaria/ml of blood (intensity of infection) from each study participant will be determined using the nucleopore filtartion technique and analysed according to the respective treatment arms at the 24 month time point.
| Enrollment: | 70 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Dr Bagrey Ngwira, London School of Hygiene |
| ClinicalTrials.gov Identifier: | NCT01213576 History of Changes |
| Other Study ID Numbers: | FED-311207 |
| Study First Received: | September 30, 2010 |
| Last Updated: | October 1, 2010 |
| Health Authority: | Malawi: National Health Sciences Research Committee |
Keywords provided by London School of Hygiene and Tropical Medicine:
|
Lymphatic filariasis microfilaria Albendazole ivermectin human immunodeficiency |
Additional relevant MeSH terms:
|
Elephantiasis, Filarial Elephantiasis Filariasis Spirurida Infections Secernentea Infections Nematode Infections Helminthiasis Parasitic Diseases Lymphedema Lymphatic Diseases Albendazole Ivermectin Anticestodal Agents |
Antiplatyhelmintic Agents Anthelmintics Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antiprotozoal Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013