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Effect of Albendazole Dose on Clearance of Filarial Worms

NCT00339417 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2017-07-02

No results posted yet for this study

Summary

This study, conducted in Mali, West Africa, will determine whether a new treatment regimen for lymphatic filariasis can eliminate the disease more quickly than the standard regimen. Lymphatic filariasis is caused by infection with very small filarial worms called Wuchereria bancrofti that are spread by mosquitoes. The disease can cause swelling of the arms, legs, breast and genitalia and can progress to permanent swelling of the legs or arms called elephantiasis. Currently, patients in Mali are treated with a single dose of 400 mg of albendazole plus two doses of 200 mcg/kg of ivermectin each year. This study will use a regimen of 800 mg of albendazole twice a year plus 200 mcg/kg of ivermectin twice a year for 2 years. The study will see if the new regimen is more effective in lowering the numbers of Wuchereria bancrofti in the blood and will examine the effects of the two treatments on the adult worms living in the lymph system.

Healthy people between 14 and 65 years of age who live in the Mali village of N'Tessoni and are infected with Wuchereria bancrofti may be eligible for this study. Candidates are screened with a medical history, a brief physical examination and blood tests to check for infection with Wuchereria bancrofti and to measure white blood cell counts.

Participants undergo the following procedures:

-First visit

Ultrasound examination to look for filarial worms in the body.

Random assignment to receive either standard treatment or the experimental regimen

Urine pregnancy test for women of child-bearing age.

Receive first treatment dose.

-6-month visit

Short history, physical examination and blood test.

Second treatment dose for subjects in experimental treatment group.

Urine pregnancy test for women of childbearing age.

-1-year visit

Short history, physical examination and blood test.

Second or third treatment dose, depending on treatment group.

Repeat ultrasound in subjects whose first ultrasound detected adult worms.

Urine pregnancy test for women of childbearing age.

-18-month visit

Short history, physical examination and blood test.

Fourth treatment dose for subjects in experimental treatment group.

Urine pregnancy test for women of childbearing age.

-24-month visit

Short history, physical examination and blood test.

Repeat ultrasound in subjects whose first ultrasound detected adult worms.

Urine pregnancy test for women of childbearing age.

Conditions

  • Lymphatic Filariasis

Interventions

DRUG

Albendazole

DRUG

Ivermectin

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Purpose
TREATMENT

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-22
Primary Completion
2008-08-01
Completion
2011-08-17

Countries

  • Mali

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00339417 on ClinicalTrials.gov