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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01213576
Other study ID # FED-311207
Secondary ID
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


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
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