Effect of Albendazole Dose on Clearance of Filarial Worms

This study has been completed.
Sponsor:
Collaborator:
Tuberculosis Research Centre, India
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00375583
First received: September 12, 2006
Last updated: April 29, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention Phase
Lymphatic Filariasis
Wuchereria Bancrofti Infection
Drug: DEC/Albendazole
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Effect of Albendazole Dose and Interval on Wuchereria Bancrofti Microfilarial Clearance in India: A Randomized, Open Label Study

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Microfilarial levels. [ Time Frame: 12 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adult worm burden. [ Time Frame: 12 and 24 months. ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: September 2006
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: DEC/Albendazole
    N/A
Detailed Description:

Albendazole and diethylcarbamazine (DEC) are currently used in combination for annual mass treatment of lymphatic filariasis in all parts of the world except Africa. Although the drugs have been donated, the cost of such programs is very high and has proven to be a major impediment to the success of programs in many countries with limited financial resources. Data from albendazole treatment of other filarial infections and one study comparing single to multi-dose DEC/albendazole in lymphatic filariasis suggest that increased dose and/or frequency of albendazole dosing may be more effective in clearing microfilariae. In this study, 50 volunteers with microfilaremic Wuchereria bancrofti infection will be randomized to receive standard annual therapy (albendazole 400 mg + DEC 300 mg) or semiannual therapy with an increased albendazole dose (albendazole 800 mg + DEC 300 mg). Microfilarial levels, as well as measures of adult worm burden (circulating antigen, ultrasound identification of adult worm nests) will be followed every six months for two years to determine whether the higher dose, more frequent regimen is more effective.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA (SCREENING):

Age 18 years to 55 years inclusive.

Both genders.

Not pregnant or breastfeeding by history.

If selected, subject must be willing to spend 3 days on the Clinical Trials Unit of the Government General Hospital, Chennai India.

If selected, subject must be willing to undergo nighttime blood draws every 6 months for 2 years.

If selected, agree to have blood stored for future studies.

Ability to understand and sign the informed consent.

EXCLUSION CRITERIA (SCREENING):

Non-volunteers.

Age less than 18 years or greater than 55 years.

Pregnant or breastfeeding by history.

INCLUSION (TREATMENT):

Age 18 years to 55 years.

Men and non-pregnant or non-breastfeeding women.

Microfilarial levels greater than 50 mf/ml.

Willingness to spend 3 days on the Clinical Trials Unit of the Government General Hospital, Chennai India.

Willingness to undergo nighttime blood draws every 6 months for 2 years.

Ability to understand and sign the informed consent.

Hb levels for inclusion greater than 9 g/dL.

Normal Cr, ALT.

Willingness to have blood stored for future studies.

EXCLUSION (TREATMENT):

Non-volunteers.

Age less than 18 years or greater than 55 years.

Pregnancy or breast-feeding.

Hgb less than or equal to 9 g/dL.

Cr greater than 1.2/100 ml.

ALT greater than 30 U.

Alcohol consumption of more than 2 beers or other alcohol-containing drink/day within a week of each drug administration.

Temperature greater than 37.5 degrees C.

Serious medical illness.

History of benzimidazole allergy.

History of DEC allergy.

Use of albendazole or DEC within past 6 months.

Unwillingness to comply with required study visits.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375583

Locations
India
Tuberculosis Research Centre
Chennai, India
Sponsors and Collaborators
Tuberculosis Research Centre, India
  More Information

Publications:
Responsible Party: Thomas B. Nutman, M.D./National Institute of Allergy and Infectious Diseases, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00375583     History of Changes
Other Study ID Numbers: 999906244, 06-I-N244
Study First Received: September 12, 2006
Last Updated: April 29, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Lymphatic Filariasis
Diethylcarbamazine
Microfilariae
Helminths
Nematode

Additional relevant MeSH terms:
Filariasis
Elephantiasis
Elephantiasis, Filarial
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Lymphedema
Lymphatic Diseases
Albendazole
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 18, 2014