- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00375583
Effect of Albendazole Dose on Clearance of Filarial Worms
Effect of Albendazole Dose and Interval on Wuchereria Bancrofti Microfilarial Clearance in India: A Randomized, Open Label Study
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Chennai, India
- Tuberculosis Research Centre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Microfilarial levels.
Time Frame: 12 months.
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12 months.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adult worm burden.
Time Frame: 12 and 24 months.
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12 and 24 months.
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Collaborators and Investigators
Publications and helpful links
General Publications
- Andrade LD, Medeiros Z, Pires ML, Pimentel A, Rocha A, Figueredo-Silva J, Coutinho A, Dreyer G. Comparative efficacy of three different diethylcarbamazine regimens in lymphatic filariasis. Trans R Soc Trop Med Hyg. 1995 May-Jun;89(3):319-21. doi: 10.1016/0035-9203(95)90561-8.
- Adjepon-Yamoah KK, Edwards G, Breckenridge AM, Orme ML, Ward SA. The effect of renal disease on the pharmacokinetics of diethylcarbamazine in man. Br J Clin Pharmacol. 1982 Jun;13(6):829-34. doi: 10.1111/j.1365-2125.1982.tb01874.x.
- Amaral F, Dreyer G, Figueredo-Silva J, Noroes J, Cavalcanti A, Samico SC, Santos A, Coutinho A. Live adult worms detected by ultrasonography in human Bancroftian filariasis. Am J Trop Med Hyg. 1994 Jun;50(6):753-7. doi: 10.4269/ajtmh.1994.50.753.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Lymphatic Diseases
- Vector Borne Diseases
- Parasitic Diseases
- Spirurida Infections
- Secernentea Infections
- Nematode Infections
- Helminthiasis
- Lymphedema
- Filariasis
- Elephantiasis, Filarial
- Elephantiasis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antiprotozoal Agents
- Antiparasitic Agents
- Anthelmintics
- Antiplatyhelmintic Agents
- Anticestodal Agents
- Albendazole
Other Study ID Numbers
- 999906244
- 06-I-N244
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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