MedTrace Logo

Effect of Albendazole Dose on Clearance of Filarial Worms

NCT00375583 · 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 Chennai, India, will determine whether a new treatment regimen of albendazole and diethylcarbamazine for lymphatic filariasis can eliminate the disease more quickly than the standard regimen. Lymphatic filariasis is caused by infection with very small filarial worms, particulalry Wuchereria bancroti, that are spread by mosquitoes. The infection can lead to swelling of the arms, legs, breast and scrotum and can progress to permanent swelling of the legs or arms called elephantiasis. The study will see if a higher and more frequent dose of albendazole is better at clearing filarial worms from the blood than the current treatment.

Healthy people between 18 and 55 years of age who are in good health and who are infected with Wuchereria bancrofti may be eligible for this 28-month study. Candidates must be willing to spend 4 days in the Government General Hospital in Chennai, India, at the beginning of the study. They are screened with a medical history, a brief physical examination, ultrasound (picture generated by sound waves) of the groin or chest, and blood tests to check for infection with Wuchereria bancrofti and to measure white blood cell counts.

Participants undergo the following procedures:

-4-day hospitalization

Random assignment to receive either standard treatment (400 mg albendazole and 300 mg DEC given once a year for 2 years) or the experimental regimen (800 mg albendazole and 300 mg DEC given twice a year for 2 years)

Urine pregnancy test for women of childbearing age

Receive first treatment dose

Monitoring for symptoms

-6-month outpatient visit

Short history, physical examination and blood test

Second treatment dose for subjects receiving 800 mg albendazole

Urine pregnancy test for women of childbearing age

-1-year outpatient 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 worm

Urine pregnancy test for women of childbearing age

-18-month outpatient visit

Short history, physical examination and blood test

Fourth treatment dose for subjects receiving 800 mg albendazole

Urine pregnancy test for women of childbearing age

-24-month outpatient visit

Short history, physical examination and blood test

Final dose of albendazole and DEC at standard doses

Repeat ultrasound in subjects whose first ultrasound detected adult worms

Urine pregnancy test for women of childbearing age

Conditions

  • Lymphatic Filariasis
  • Wuchereria Bancrofti Infection

Interventions

DRUG

DEC/Albendazole

Sponsors & Collaborators

  • Tuberculosis Research Centre, India

    collaborator OTHER_GOV

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Purpose
TREATMENT

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-09
Primary Completion
2011-04-28
Completion
2011-04-28

Countries

  • India

Study Locations

More Related Trials

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 NCT00375583 on ClinicalTrials.gov