Effect of Albendazole Dose on Treatment of Lymphatic Filariasis

July 30, 2015 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Effect of Albendazole Dose and Interval on Brugia Malayi Microfilarial Clearance in India: A Randomized, Open Label Study

This study is conducted in Kerala, India. It will determine whether a new treatment regimen of albendazole and diethylcarbamazine (DEC) for lymphatic filariasis can eliminate the disease more quickly than the standard regimen. Lymphatic filariasis is caused by infection with very small parasitic worms that are spread by mosquitoes. The disease can cause 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 filarial worms may be eligible for this study.

Participants undergo the following procedures:

3-day hospital stay at the Filariasis Chemotherapy Unit of the T.D. Medical College Hospital in Kerala, India

  • Random assignment to receive either: 400 mg albendazole and DEC 300 mg given once a year for 2 years (standard treatment); or 800 mg albendazole and DEC 300 mg given once a year for 2 years; or 800 mg albendazole and DEC 300 mg given twice a year for 2 years.
  • Urine pregnancy test for women of childbearing age .
  • Ultrasound test to look for filarial worms.
  • Treatment dose.

  • Monitoring for symptoms

    6-month 3-day hospital stay

  • Medical history, physical examination and blood test.
  • Repeat ultrasound in subjects whose first ultrasound detected adult worms.
  • Treatment dose for subjects receiving medicine every 6 months.

  • Urine pregnancy test for women of childbearing age.

    1-year 3-day hospital stay

  • Medical history, physical examination and blood test.
  • Treatment dose.
  • Repeat ultrasound in subjects whose first ultrasound detected adult worms.

  • Urine pregnancy test for women of childbearing age.

    18-month 3-day hospital stay

  • Medical history, physical examination and blood test.
  • Treatment dose for subjects receiving medicine every 6 months.

  • Urine pregnancy test for women of childbearing age.

    24-month 3-day hospital stay

  • Medical history, physical examination and blood test.
  • Treatment dose.
  • Repeat ultrasound in subjects whose first ultrasound detected adult worms.
  • Urine pregnancy test for women of childbearing age.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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, 75 volunteers with microfilaremic Brugia malayi infection will be randomized to receive standard annual therapy (albendazole 400 mg + DEC 300 mg), annual therapy with increased dosing of albendazole (albendazole 800 mg + DEC 300 mg), or semiannual therapy with an increased albendazole dose (albendazole 800 mg + DEC 300 mg). Microfilarial levels will be followed every 6 months for 2 years to determine whether the higher dose, and/or the more frequent regimen, is more effective.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Alleppey, Kerala, India
        • Filariasis Chemotherapy Unit (FCU), T.D. Medical Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:

Inclusion Criteria for Screening:

  • Age 18 years to 55 years inclusive
  • Both genders
  • Not pregnant or breastfeeding by history
  • If selected, subjects must be willing to spend 3 days on the Filariasis Chemotherapy Unit at the T.D. Medical College Hospital, Alleppey, Kerala, India
  • If selected, subjects must be willing to undergo nighttime blood draws once every 6 months and Doppler ultrasound twice yearly for 2 years
  • If selected, agree to have blood stored for future studies
  • Ability to understand and give informed consent

Inclusion Criteria for Treatment:

  • Age 18 to 55 years inclusive
  • Men and non-pregnant or non-breast feeding women
  • Microfilarial levels greater than 50mf/mL
  • Willingness to spend 3 days on the Filariasis Chemotherapy Unit at the T.D. Medical College Hospital, Alleppey, Kerala, India every 6 months for 2 years
  • Willingness to undergo nighttime blood draws once every 6 months for 2 years
  • Ability to understand and give informed consent
  • Hemaglobin (Hgb) levels for inclusion greater than 9 g/dL
  • Creatinine (Cr) less than or equal to 1.2 mg/dL
  • Alanine aminotransferase (ALT) less than 30 U/L
  • Willingness to have blood stored for future studies

EXCLUSION CRITERIA:

Exclusion Criteria for Screening:

  • Age less than 18 years or greater than 55 years
  • Pregnant or breast feeding by history

Exclusion Criteria for Treatment:

  • Non-volunteers
  • Age less than 18 years or greater than 55 years
  • Pregnant or breast feeding
  • Hgb levels less than or equal to 9 g/dL
  • Cr greater than 1.3 mg/dL
  • ALT greater than 30 U/L
  • Alcohol consumption of more than 2 beers or other alcohol-containing drinks/day within a week of each drug administration
  • Temperature greater than 37.5 degrees Celsius
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Diethylcarbamazine/Albendazole -STD
Standard therapy of DEC (300mg) and albendazole (400mg) yearly
Drug: Albendazole
Comparing 400 mg to 800 mg dose
Other Names:
  • Zentel
Drug: Diethylcarbamazine
Providing diethylcarbamazine more frequently in combination with albendazole
Other Names:
  • Banocide
Active Comparator: Diethylcarbamazine/Albendazole- HD1
High dose of DEC (300mg) and albendazole (800mg) yearly
Drug: Albendazole
Comparing 400 mg to 800 mg dose
Other Names:
  • Zentel
Drug: Diethylcarbamazine
Providing diethylcarbamazine more frequently in combination with albendazole
Other Names:
  • Banocide
Active Comparator: Diethylcarbamazine/Albendazole-HD2
High dose of DEC (300mg) and albendazole (800mg) twice yearly (every 6 months)
Drug: Albendazole
Comparing 400 mg to 800 mg dose
Other Names:
  • Zentel
Drug: Diethylcarbamazine
Providing diethylcarbamazine more frequently in combination with albendazole
Other Names:
  • Banocide

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Microfilarial Counts at 1 Year
Time Frame: 1 year from time enrolled
Night time microfilarial counts at 1 year
1 year from time enrolled

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adult Worm Burdens at 2 Years
Time Frame: 2 years from the time enrolled.
Doppler detected worm nests at 2 years
2 years from the time enrolled.
Microfilarial Levels at 2 Years
Time Frame: 2 years from time enrolled
Night time microfilarial levels at 2 years
2 years from time enrolled
Brugia Specific Immunoglobulin G4 (IgG4) Antibodies
Time Frame: 2 years
IgG4 antibodies directed against Brugia malayi antigen
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 999907197
  • 07-I-N197 (Other Identifier: NIAID IRB)

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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