Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 38 for:    "Elephantiasis" | "Anthelmintics"

Effect of Albendazole Dose on Treatment of Lymphatic Filariasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00511004
Recruitment Status : Completed
First Posted : August 3, 2007
Results First Posted : August 31, 2015
Last Update Posted : August 31, 2015
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Tracking Information
First Submitted Date  ICMJE August 2, 2007
First Posted Date  ICMJE August 3, 2007
Results First Submitted Date  ICMJE July 2, 2015
Results First Posted Date  ICMJE August 31, 2015
Last Update Posted Date August 31, 2015
Study Start Date  ICMJE July 2007
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2015)
Microfilarial Counts at 1 Year [ Time Frame: 1 year from time enrolled ]
Night time microfilarial counts at 1 year
Original Primary Outcome Measures  ICMJE
 (submitted: August 2, 2007)
To determine whether increasing the albendazole dose or the frequency of treatment with DEC/albendazole is mor effective than the current proved mass treatment regimen at clearing microfilaremia as assessed by microfilarial counts at one year.
Change History Complete list of historical versions of study NCT00511004 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2015)
  • Adult Worm Burdens at 2 Years [ Time Frame: 2 years from the time enrolled. ]
    Doppler detected worm nests at 2 years
  • Microfilarial Levels at 2 Years [ Time Frame: 2 years from time enrolled ]
    Night time microfilarial levels at 2 years
  • Brugia Specific Immunoglobulin G4 (IgG4) Antibodies [ Time Frame: 2 years ]
    IgG4 antibodies directed against Brugia malayi antigen
Original Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2007)
To assess effect on adult worm burdens, microfilariae at 2 yeard, and Brugia specific IgG4.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Albendazole Dose on Treatment of Lymphatic Filariasis
Official Title  ICMJE Effect of Albendazole Dose and Interval on Brugia Malayi Microfilarial Clearance in India: A Randomized, Open Label Study
Brief Summary

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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphatic Filariasis
Intervention  ICMJE
  • Drug: Albendazole
    Comparing 400 mg to 800 mg dose
    Other Name: Zentel
  • Drug: Diethylcarbamazine
    Providing diethylcarbamazine more frequently in combination with albendazole
    Other Name: Banocide
Study Arms  ICMJE
  • Active Comparator: Diethylcarbamazine/Albendazole -STD
    Standard therapy of DEC (300mg) and albendazole (400mg) yearly
    Interventions:
    • Drug: Albendazole
    • Drug: Diethylcarbamazine
  • Active Comparator: Diethylcarbamazine/Albendazole- HD1
    High dose of DEC (300mg) and albendazole (800mg) yearly
    Interventions:
    • Drug: Albendazole
    • Drug: Diethylcarbamazine
  • Active Comparator: Diethylcarbamazine/Albendazole-HD2
    High dose of DEC (300mg) and albendazole (800mg) twice yearly (every 6 months)
    Interventions:
    • Drug: Albendazole
    • Drug: Diethylcarbamazine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 30, 2015)
40
Original Enrollment  ICMJE
 (submitted: August 2, 2007)
0
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00511004
Other Study ID Numbers  ICMJE 999907197
07-I-N197 ( Other Identifier: NIAID IRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas B Nutman, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP