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Effect of Albendazole Dose on Treatment of Lymphatic Filariasis

NCT00511004 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-08-31

Study results available
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Summary

This study is conducted in Kerala, India. It will determine whether a new treatment regimen of albendazole and diethylcarbamazine (DEC) for lymphatic filariasis can eliminate the disease more quickly than the standard regimen. Lymphatic filariasis is caused by infection with very small parasitic worms that are spread by mosquitoes. The disease can cause 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 filarial worms may be eligible for this study.

Participants undergo the following procedures:

3-day hospital stay at the Filariasis Chemotherapy Unit of the T.D. Medical College Hospital in Kerala, India

* Random assignment to receive either: 400 mg albendazole and DEC 300 mg given once a year for 2 years (standard treatment); or 800 mg albendazole and DEC 300 mg given once a year for 2 years; or 800 mg albendazole and DEC 300 mg given twice a year for 2 years.
* Urine pregnancy test for women of childbearing age .
* Ultrasound test to look for filarial worms.
* Treatment dose.
* Monitoring for symptoms

6-month 3-day hospital stay
* Medical history, physical examination and blood test.
* Repeat ultrasound in subjects whose first ultrasound detected adult worms.
* Treatment dose for subjects receiving medicine every 6 months.
* Urine pregnancy test for women of childbearing age.

1-year 3-day hospital stay
* Medical history, physical examination and blood test.
* Treatment dose.
* Repeat ultrasound in subjects whose first ultrasound detected adult worms.
* Urine pregnancy test for women of childbearing age.

18-month 3-day hospital stay
* Medical history, physical examination and blood test.
* Treatment dose for subjects receiving medicine every 6 months.
* Urine pregnancy test for women of childbearing age.

24-month 3-day hospital stay
* Medical history, physical examination and blood test.
* Treatment dose.
* Repeat ultrasound in subjects whose first ultrasound detected adult worms.
* Urine pregnancy test for women of childbearing age.

Conditions

  • Lymphatic Filariasis

Interventions

DRUG

Albendazole

Comparing 400 mg to 800 mg dose

DRUG

Diethylcarbamazine

Providing diethylcarbamazine more frequently in combination with albendazole

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Thomas B Nutman, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • India

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 NCT00511004 on ClinicalTrials.gov