Lymphatic FilariasisPhase 2NCT00339417
Effect of Albendazole Dose on Clearance of Filarial Worms
A Phase 2 study testing Albendazole and Ivermectin in people with Lymphatic Filariasis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Lymphatic Filariasis
- What is being tested?
- Albendazole and Ivermectin
- How many people
- 1,000 participants
- Where
- 1 siteMali
- Study dates
- 22 Feb 2006to 17 Aug 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- age 14 to 65 years.
- men and women.*
- Wb microfilarial count greater than or equal to 50 mf/ml.
Who cannot join
- non-volunteers.
- age less than 14 or greater than 65.
- pregnant by history.
- non-volunteers.
- age less than 14 or greater than 65.
- pregnancy.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Mali1 site
University of Bamako, Faculty of Medicine, Pharmacy and Odontostomatology
Bamako
About this study
Official title: Effect of Albendazole and Ivermectin Dose on Wuchereria Bancrofti Microfilarial Clearance in Mali: A Randomized, Open Label Study
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.
Read more
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.
Read the 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.
- Conditions
- Lymphatic Filariasis
- Being tested
- Albendazole, Ivermectin
- Keywords
- Lymphatic Filariasis, Chemotherapy
- Medical subject headings
- Elephantiasis, Filarial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbendazoleDrug
IvermectinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Wb microfilarial levels
Measured: 12 months
Secondary outcomes (1)
Adult worm burden as assessed by circulating antigen levels and visualization of worm nests by ultrasound
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start22 Feb 2006
- Primary completion1 Aug 2008
- Study completion17 Aug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lymphatic FilariasisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339417
- Sponsor's protocol ID
- 999906107
- Other IDs
- 06-I-N107
- Status last verified
- 17 Aug 2011
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 10466981Addiss 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.
PubMed 9274584Horton 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.
PubMed 11386686
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Albendazole and Ivermectin Dose on Wuchereria Bancrofti Microfilarial Clearance in Mali: A Randomized, Open Label Study
- ClinicalTrials.gov ID
- NCT00339417
- Acronym / sponsor ID
- 999906107
- Conditions
- Lymphatic Filariasis
- Keywords
- Lymphatic Filariasis, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 22 Feb 2006
- Primary completion
- 1 Aug 2008 (actual)
- Study completion
- 17 Aug 2011 (actual)
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- age 14 to 65.
- men and women*.
- age 14 to 65 years.
- men and women.*
- Wb microfilarial count greater than or equal to 50 mf/ml.
Key exclusion criteria (12 listed)
- non-volunteers.
- age less than 14 or greater than 65.
- pregnant by history.
- non-volunteers.
- age less than 14 or greater than 65.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albendazole | Drug | – |
| Ivermectin | Drug | – |
Primary outcome
Wb microfilarial levels
Time frame: 12 months
1 secondary outcome
Adult worm burden as assessed by circulating antigen levels and visualization of worm nests by ultrasound
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 10466981Beach 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.
- Background: PubMed 9274584Addiss 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.
- Background: PubMed 11386686Horton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Albendazole and Ivermectin in people with Lymphatic Filariasis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wb microfilarial levels (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00339417, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.