Lymphatic FilariasisPhase 2NCT00375583
Effect of Albendazole Dose on Clearance of Filarial Worms
A Phase 2 study testing DEC/Albendazole in people with Lymphatic Filariasis and Wuchereria Bancrofti Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Lymphatic Filariasis, Wuchereria Bancrofti Infection
- What is being tested?
- DEC/Albendazole
- How many people
- 1,000 participants
- Where
- 1 siteIndia
- Study dates
- 9 Sep 2006to 28 Apr 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- Ability to understand and sign the informed consent.
- 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.
Who cannot join
- Non-volunteers.
- Age less than 18 years or greater than 55 years.
- Pregnant or breastfeeding by history.
- Non-volunteers.
- Age less than 18 years or greater than 55 years.
- Pregnancy or breast-feeding.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
Read the 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.
- Being tested
- DEC/Albendazole
- Keywords
- Lymphatic Filariasis, Diethylcarbamazine, Microfilariae, Helminths, Nematode
- Medical subject headings
- Elephantiasis, Filarial, Enterobiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEC/AlbendazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Microfilarial levels.
Measured: 12 months.
Secondary outcomes (1)
Adult worm burden.
Measured: 12 and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2006 (estimated)
- Study start9 Sep 2006
- Primary completion28 Apr 2011
- Study completion28 Apr 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
- Collaborators
- Tuberculosis Research Centre, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375583
- Sponsor's protocol ID
- 999906244
- Other IDs
- 06-I-N244
- Status last verified
- 28 Apr 2011
- First submitted
- 12 Sep 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 7093114Andrade 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.
PubMed 7660449Amaral 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.
PubMed 8024070
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 Dose and Interval on Wuchereria Bancrofti Microfilarial Clearance in India: A Randomized, Open Label Study
- ClinicalTrials.gov ID
- NCT00375583
- Acronym / sponsor ID
- 999906244
- Keywords
- Lymphatic Filariasis, Diethylcarbamazine, Microfilariae, Helminths, Nematode
- 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
- Collaborators
- Tuberculosis Research Centre, India
- Study start
- 9 Sep 2006
- Primary completion
- 28 Apr 2011 (actual)
- Study completion
- 28 Apr 2011 (actual)
- First posted
- 13 Sep 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 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
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (16 listed)
- Non-volunteers.
- Age less than 18 years or greater than 55 years.
- Pregnant or breastfeeding by history.
- Non-volunteers.
- Age less than 18 years or greater than 55 years.
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 |
|---|---|---|
| DEC/Albendazole | Drug | – |
Primary outcome
Microfilarial levels.
Time frame: 12 months.
1 secondary outcome
Adult worm burden.
Time frame: 12 and 24 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 7093114Adjepon-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.
- Background: PubMed 7660449Andrade 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.
- Background: PubMed 8024070Amaral 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.
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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 DEC/Albendazole in people with Lymphatic Filariasis and Wuchereria Bancrofti Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in India.
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 16 inclusion and 16 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 India. 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?
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 NCT00375583, 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.