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

Lymphatic Filariasis Clinical Trial

— FED  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01213576
• Other study ID #: FED-311207
• Status: Terminated
• Phase: N/A
• First received: September 30, 2010
• Last updated: February 26, 2015
• Start date: January 2009
• Est. completion date: February 2012

Study information

• Verified date: February 2015
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malawi: National Health Sciences Research Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Filariasis
• Lymphatic Filariasis

Intervention

Drug:
• Albendazole 400mg and ivermectin 200mcg/kg
400 mg orally given annually
• Albendazole and ivermectin
albendazole 800 mg and ivermectin 400mg orally given annually
• Albendazole 400mg and ivermectin 200mcg/kg
Albendazole 400mg and ivermectin 200mcg/kg given twice a year
• albendazole 800mg and ivermectin 400mcg/kg bi-annually
albendazole 800mg and ivermectin 400mcg/kg given twice a year

Locations

Country	Name	City	State
Malawi	Karonga Prevention Study	Karonga

Sponsors (2)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Emory University

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months	No
Secondary	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	24 months	No