Effect of Albendazole Dose on Treatment of Lymphatic Filariasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT00511004
First received: August 2, 2007
Last updated: July 30, 2015
Last verified: July 2015
Results First Received: July 2, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphatic Filariasis
Interventions: Drug: Albendazole
Drug: Diethylcarbamazine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Adults living in Kerala, India with Brugia malayi microfilaremia were recruited from field sites around the city of Alleppey and the study performed in the outpatient department of the TD Medical College.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Standard Therapy Annual DEC/ALB Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
High Dose Annual DEC/ALB Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
High Dose Semiannual DEC/ALB Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)

Participant Flow:   Overall Study
    Standard Therapy Annual DEC/ALB     High Dose Annual DEC/ALB     High Dose Semiannual DEC/ALB  
STARTED     13     13     14  
COMPLETED     13     13     10  
NOT COMPLETED     0     0     4  
Lost to Follow-up                 0                 0                 4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Standard Therapy Annual DEC/ALB Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
High Dose Annual DEC/ALB Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
High Dose Semiannual DEC/ALB Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
Total Total of all reporting groups

Baseline Measures
    Standard Therapy Annual DEC/ALB     High Dose Annual DEC/ALB     High Dose Semiannual DEC/ALB     Total  
Number of Participants  
[units: participants]
  13     13     14     40  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     13     13     14     40  
>=65 years     0     0     0     0  
Age  
[units: Years]
Median (Full Range)
  36  
  (18 to 50)  
  39  
  (18 to 50)  
  37  
  (19 to 54)  
  37  
  (18 to 54)  
Gender  
[units: participants]
       
Female     9     10     10     29  
Male     4     3     4     11  
Region of Enrollment  
[units: participants]
       
India     13     13     14     40  
Blood microfilaremia (mf/ml)  
[units: MF/ML]
Median (Full Range)
  412  
  (64 to 912)  
  264  
  (112 to 1244)  
  384  
  (108 to 748)  
  384  
  (64 to 1244)  



  Outcome Measures
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1.  Primary:   Microfilarial Counts at 1 Year   [ Time Frame: 1 year from time enrolled ]

2.  Secondary:   Adult Worm Burdens at 2 Years   [ Time Frame: 2 years from the time enrolled. ]

3.  Secondary:   Microfilarial Levels at 2 Years   [ Time Frame: 2 years from time enrolled ]

4.  Secondary:   Brugia Specific Immunoglobulin G4 (IgG4) Antibodies   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study never fully enrolled so sample size was smaller than hoped for.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Thomas B. Nutman
Organization: NIAID
phone: 301-496-5398
e-mail: tnutman@niaid.nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT00511004     History of Changes
Other Study ID Numbers: 999907197
07-I-N197 ( Other Identifier: NIAID IRB )
Study First Received: August 2, 2007
Results First Received: July 2, 2015
Last Updated: July 30, 2015
Health Authority: United States: Federal Government