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Effect of Albendazole Dose on Treatment of Lymphatic Filariasis

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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) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphatic Filariasis
Interventions Drug: Albendazole
Drug: Diethylcarbamazine
Enrollment 40
Recruitment Details 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  
Arm/Group Title Standard Therapy Annual DEC/ALB High Dose Annual DEC/ALB High Dose Semiannual DEC/ALB
Hide Arm/Group Description Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg) Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg) Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
Period Title: Overall Study
Started 13 13 14
Completed 13 13 10
Not Completed 0 0 4
Reason Not Completed
Lost to Follow-up             0             0             4
Arm/Group Title Standard Therapy Annual DEC/ALB High Dose Annual DEC/ALB High Dose Semiannual DEC/ALB Total
Hide Arm/Group Description Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg) Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg) Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg) Total of all reporting groups
Overall Number of Baseline Participants 13 13 14 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 14 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
 100.0%
13
 100.0%
14
 100.0%
40
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants 13 participants 14 participants 40 participants
36
(18 to 50)
39
(18 to 50)
37
(19 to 54)
37
(18 to 54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 14 participants 40 participants
Female
9
  69.2%
10
  76.9%
10
  71.4%
29
  72.5%
Male
4
  30.8%
3
  23.1%
4
  28.6%
11
  27.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
India Number Analyzed 13 participants 13 participants 14 participants 40 participants
13 13 14 40
Blood microfilaremia (mf/ml)  
Median (Full Range)
Unit of measure:  MF/ML
Number Analyzed 13 participants 13 participants 14 participants 40 participants
412
(64 to 912)
264
(112 to 1244)
384
(108 to 748)
384
(64 to 1244)
1.Primary Outcome
Title Microfilarial Counts at 1 Year
Hide Description Night time microfilarial counts at 1 year
Time Frame 1 year from time enrolled
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Therapy Annual DEC/ALB High Dose Annual DEC/ALB High Dose Semiannual DEC/ALB
Hide Arm/Group Description:
Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
Overall Number of Participants Analyzed 13 13 13
Median (Full Range)
Unit of Measure: MF/ML
0
(0 to 20)
0
(0 to 12)
0
(0 to 9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Therapy Annual DEC/ALB, High Dose Annual DEC/ALB, High Dose Semiannual DEC/ALB
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.2
Comments Adjusted for multiple comparisons
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Adult Worm Burdens at 2 Years
Hide Description Doppler detected worm nests at 2 years
Time Frame 2 years from the time enrolled.
Hide Outcome Measure Data
Hide Analysis Population Description
By 2 years, 4 subjects in High Dose Group lost to followup
Arm/Group Title Standard Therapy Annual DEC/ALB High Dose Annual DEC/ALB High Dose Semiannual DEC/ALB
Hide Arm/Group Description:
Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
Overall Number of Participants Analyzed 13 13 10
Median (Full Range)
Unit of Measure: Number of nests
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Therapy Annual DEC/ALB, High Dose Annual DEC/ALB, High Dose Semiannual DEC/ALB
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Microfilarial Levels at 2 Years
Hide Description Night time microfilarial levels at 2 years
Time Frame 2 years from time enrolled
Hide Outcome Measure Data
Hide Analysis Population Description
By 2 years, 4 subjects in High Dose Group lost to followup
Arm/Group Title Diethylcarbamazine/Albendazole -STD Diethylcarbamazine/Albendazole- HD1 Diethylcarbamazine/Albendazole-HD2
Hide Arm/Group Description:

Standard therapy of diethylcarbamazine (DEC) (300mg) and albendazole (400mg) yearly

Albendazole: Comparing 400 mg to 800 mg dose

Diethylcarbamazine: Providing diethylcarbamazine more frequently in combination with albendazole

High dose of DEC (300mg) and albendazole (800mg) yearly

Albendazole: Comparing 400 mg to 800 mg dose

Diethylcarbamazine: Providing diethylcarbamazine more frequently in combination with albendazole

High dose of DEC (300mg) and albendazole (800mg) twice yearly (every 6 months)

Albendazole: Comparing 400 mg to 800 mg dose

Diethylcarbamazine: Providing diethylcarbamazine more frequently in combination with albendazole

Overall Number of Participants Analyzed 13 13 10
Median (Full Range)
Unit of Measure: MF/ML
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
4.Secondary Outcome
Title Brugia Specific Immunoglobulin G4 (IgG4) Antibodies
Hide Description IgG4 antibodies directed against Brugia malayi antigen
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
By 2 years, 4 subjects in High Dose Group lost to followup
Arm/Group Title Standard Therapy Annual DEC/ALB High Dose Annual DEC/ALB High Dose Semiannual DEC/ALB
Hide Arm/Group Description:
Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
Overall Number of Participants Analyzed 13 13 10
Median (Full Range)
Unit of Measure: ng/ml
150
(0 to 1000)
224
(0 to 2100)
128
(0 to 650)
Time Frame Every 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Therapy Annual DEC/ALB High Dose Annual DEC/ALB High Dose Semiannual DEC/AC=LB
Hide Arm/Group Description Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg) Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg) Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
All-Cause Mortality
Standard Therapy Annual DEC/ALB High Dose Annual DEC/ALB High Dose Semiannual DEC/AC=LB
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Standard Therapy Annual DEC/ALB High Dose Annual DEC/ALB High Dose Semiannual DEC/AC=LB
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/13 (0.00%)      0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Therapy Annual DEC/ALB High Dose Annual DEC/ALB High Dose Semiannual DEC/AC=LB
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/13 (69.23%)      8/13 (61.54%)      11/14 (78.57%)    
Gastrointestinal disorders       
Nausea/Vomiting * 1  1/13 (7.69%)  1 1/13 (7.69%)  1 0/14 (0.00%)  0
Investigations       
Fever * 1  5/13 (38.46%)  5 4/13 (30.77%)  4 4/14 (28.57%)  4
Musculoskeletal and connective tissue disorders       
Myalgia * 1  9/13 (69.23%)  9 8/13 (61.54%)  8 11/14 (78.57%)  11
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Custom
Study never fully enrolled so sample size was smaller than hoped for.
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
Layout table for Results Point of Contact information
Name/Title: Thomas B. Nutman
Organization: NIAID
Phone: 301-496-5398
EMail: tnutman@niaid.nih.gov
Layout table for additonal information
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 )
First Submitted: August 2, 2007
First Posted: August 3, 2007
Results First Submitted: July 2, 2015
Results First Posted: August 31, 2015
Last Update Posted: August 31, 2015