Effect of Albendazole Dose on Clearance of Filarial Worms

NCT00375583 | Completed Phase 2

• 2 other identifiers: 99990624406-I-N244
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lymphatic Filariasis; Diethylcarbamazine; Microfilariae; Helminths; Nematode

Outcome Measures

Primary Outcomes (1)

• Microfilarial levels.

  12 months.

Secondary Outcomes (1)

• Adult worm burden.

  12 and 24 months.

Interventions

DEC/Albendazole DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Non-volunteers.
• Age less than 18 years or greater than 55 years.
• Pregnant or breastfeeding by history.
• 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.
• Normal Cr, ALT.
• Willingness to have blood stored for future studies.
• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Tuberculosis Research Centre, India: collaborator

Study Sites (1)

Tuberculosis Research Centre

Chennai, India

Location

Related Publications (3)

• 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.

  PMID: 7093114 BACKGROUND

• 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.

  PMID: 7660449 BACKGROUND

• 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.

  PMID: 8024070 BACKGROUND

MeSH Terms

Conditions

Elephantiasis, Filarial; Enterobiasis

Condition Hierarchy (Ancestors)

Filariasis; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Oxyuriasis; Oxyurida Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 12, 2006
• First Posted: September 13, 2006
• Study Start: September 9, 2006
• Primary Completion: April 28, 2011
• Study Completion: April 28, 2011
• Last Updated: July 2, 2017

Record last verified: 2011-04-28

Locations

IN (1)