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Effect of Albendazole Dose on Clearance of Filarial Worms

Primary Purpose

Lymphatic Filariasis

Status
Completed
Phase
Phase 2
Locations
Mali
Study Type
Interventional
Intervention
Albendazole
Ivermectin
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphatic Filariasis focused on measuring Lymphatic Filariasis, Chemotherapy

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA (Screening): age 14 to 65. men and women*. Please note: women are not permitted to leave their homes at night without the approval of their husband or, if they are not married, a parent or male guardian. Since this protocol involves blood drawing at night, such approval is necessary for participation. EXCLUSION CRITERIA (Screening): non-volunteers. age less than 14 or greater than 65. pregnant by history. INCLUSION CRITERIA (Treatment): age 14 to 65 years. men and women.* Wb microfilarial count greater than or equal to 50 mf/ml. EXCLUSION CRITERIA (Treatment): non-volunteers. age less than 14 or greater than 65. pregnancy. Hgb less than 9 g/dl. Heavy alcohol use (more than 7 beer or other alcohol-containing drink/week). Temperature greater than 37.5C or other serious medical illnesses. history of benzimidazole allergy. history of ivermectin allergy. use of albendazole or ivermectin within the past 6 months.

Sites / Locations

  • University of Bamako, Faculty of Medicine, Pharmacy and Odontostomatology

Outcomes

Primary Outcome Measures

Wb microfilarial levels

Secondary Outcome Measures

Adult worm burden as assessed by circulating antigen levels and visualization of worm nests by ultrasound

Full Information

First Posted
June 19, 2006
Last Updated
June 30, 2017
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00339417
Brief Title
Effect of Albendazole Dose on Clearance of Filarial Worms
Official Title
Effect of Albendazole and Ivermectin Dose on Wuchereria Bancrofti Microfilarial Clearance in Mali: A Randomized, Open Label Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 17, 2011
Overall Recruitment Status
Completed
Study Start Date
February 22, 2006 (undefined)
Primary Completion Date
August 1, 2008 (Actual)
Study Completion Date
August 17, 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
This study, conducted in Mali, West Africa, will determine whether a new treatment regimen for lymphatic filariasis can eliminate the disease more quickly than the standard regimen. Lymphatic filariasis is caused by infection with very small filarial worms called Wuchereria bancrofti that are spread by mosquitoes. The disease can cause swelling of the arms, legs, breast and genitalia and can progress to permanent swelling of the legs or arms called elephantiasis. Currently, patients in Mali are treated with a single dose of 400 mg of albendazole plus two doses of 200 mcg/kg of ivermectin each year. This study will use a regimen of 800 mg of albendazole twice a year plus 200 mcg/kg of ivermectin twice a year for 2 years. The study will see if the new regimen is more effective in lowering the numbers of Wuchereria bancrofti in the blood and will examine the effects of the two treatments on the adult worms living in the lymph system. Healthy people between 14 and 65 years of age who live in the Mali village of N'Tessoni and are infected with Wuchereria bancrofti may be eligible for this study. Candidates are screened with a medical history, a brief physical examination and blood tests to check for infection with Wuchereria bancrofti and to measure white blood cell counts. Participants undergo the following procedures: -First visit Ultrasound examination to look for filarial worms in the body. Random assignment to receive either standard treatment or the experimental regimen Urine pregnancy test for women of child-bearing age. Receive first treatment dose. -6-month visit Short history, physical examination and blood test. Second treatment dose for subjects in experimental treatment group. Urine pregnancy test for women of childbearing age. -1-year 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 worms. Urine pregnancy test for women of childbearing age. -18-month visit Short history, physical examination and blood test. Fourth treatment dose for subjects in experimental treatment group. Urine pregnancy test for women of childbearing age. -24-month visit Short history, physical examination and blood test. Repeat ultrasound in subjects whose first ultrasound detected adult worms. Urine pregnancy test for women of childbearing age.
Detailed Description
Albendazole and ivermectin are currently used in combination for annual mass treatment of lymphatic filariasis in 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. Furthermore, the optimal dose of ivermectin for the treatment of lymphatic filariasis is greater than that being used in the current mass treatment program. In this study, 50 volunteers with microfilaremic Wuchereria bancrofti infection will be randomized to receive standard annual therapy (albendazole 400 mg + ivermectin 150 mcg/kg) or semiannual therapy with an increased albendazole dose (albendazole 800 mg + ivermectin 400 mcg/kg). If adequate numbers of microfilaremic subjects are recruited, an additional 25 volunteers will receive annual therapy with the increased dose combination. 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 three years to assess the effects of the treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphatic Filariasis
Keywords
Lymphatic Filariasis, Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Albendazole
Intervention Type
Drug
Intervention Name(s)
Ivermectin
Primary Outcome Measure Information:
Title
Wb microfilarial levels
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Adult worm burden as assessed by circulating antigen levels and visualization of worm nests by ultrasound
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA (Screening): age 14 to 65. men and women*. Please note: women are not permitted to leave their homes at night without the approval of their husband or, if they are not married, a parent or male guardian. Since this protocol involves blood drawing at night, such approval is necessary for participation. EXCLUSION CRITERIA (Screening): non-volunteers. age less than 14 or greater than 65. pregnant by history. INCLUSION CRITERIA (Treatment): age 14 to 65 years. men and women.* Wb microfilarial count greater than or equal to 50 mf/ml. EXCLUSION CRITERIA (Treatment): non-volunteers. age less than 14 or greater than 65. pregnancy. Hgb less than 9 g/dl. Heavy alcohol use (more than 7 beer or other alcohol-containing drink/week). Temperature greater than 37.5C or other serious medical illnesses. history of benzimidazole allergy. history of ivermectin allergy. use of albendazole or ivermectin within the past 6 months.
Facility Information:
Facility Name
University of Bamako, Faculty of Medicine, Pharmacy and Odontostomatology
City
Bamako
Country
Mali

12. IPD Sharing Statement

Citations:
PubMed Identifier
10466981
Citation
Beach MJ, Streit TG, Addiss DG, Prospere R, Roberts JM, Lammie PJ. Assessment of combined ivermectin and albendazole for treatment of intestinal helminth and Wuchereria bancrofti infections in Haitian schoolchildren. Am J Trop Med Hyg. 1999 Mar;60(3):479-86. doi: 10.4269/ajtmh.1999.60.479.
Results Reference
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PubMed Identifier
9274584
Citation
Addiss DG, Beach MJ, Streit TG, Lutwick S, LeConte FH, Lafontant JG, Hightower AW, Lammie PJ. Randomised placebo-controlled comparison of ivermectin and albendazole alone and in combination for Wuchereria bancrofti microfilaraemia in Haitian children. Lancet. 1997 Aug 16;350(9076):480-4. doi: 10.1016/S0140-6736(97)02231-9. Erratum In: Lancet 1997 Oct 4;350(9083):1036.
Results Reference
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PubMed Identifier
11386686
Citation
Horton J, Witt C, Ottesen EA, Lazdins JK, Addiss DG, Awadzi K, Beach MJ, Belizario VY, Dunyo SK, Espinel M, Gyapong JO, Hossain M, Ismail MM, Jayakody RL, Lammie PJ, Makunde W, Richard-Lenoble D, Selve B, Shenoy RK, Simonsen PE, Wamae CN, Weerasooriya MV. An analysis of the safety of the single dose, two drug regimens used in programmes to eliminate lymphatic filariasis. Parasitology. 2000;121 Suppl:S147-60. doi: 10.1017/s0031182000007423.
Results Reference
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Effect of Albendazole Dose on Clearance of Filarial Worms

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