Trial Outcomes & Findings for Effect of Albendazole Dose on Treatment of Lymphatic Filariasis (NCT NCT00511004)

NCT ID: NCT00511004

Last Updated: 2015-08-31

Results Overview

Night time microfilarial counts at 1 year

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 40 participants
• Primary outcome timeframe: 1 year from time enrolled
• Results posted on: 2015-08-31

Participant Flow

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.

Participant milestones

Measure	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)
Overall Study STARTED	13	13	14
Overall Study COMPLETED	13	13	10
Overall Study NOT COMPLETED	0	0	4

Reasons for withdrawal

Measure	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)
Overall Study Lost to Follow-up	0	0	4

Baseline Characteristics

Effect of Albendazole Dose on Treatment of Lymphatic Filariasis

Baseline characteristics by cohort

Measure	Standard Therapy Annual DEC/ALB n=13 Participants Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)	High Dose Annual DEC/ALB n=13 Participants Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)	High Dose Semiannual DEC/ALB n=14 Participants Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	13 Participants n=7 Participants	14 Participants n=5 Participants	40 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	36 Years n=5 Participants	39 Years n=7 Participants	37 Years n=5 Participants	37 Years n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	29 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants
Region of Enrollment India	13 participants n=5 Participants	13 participants n=7 Participants	14 participants n=5 Participants	40 participants n=4 Participants
Blood microfilaremia (mf/ml)	412 MF/ML n=5 Participants	264 MF/ML n=7 Participants	384 MF/ML n=5 Participants	384 MF/ML n=4 Participants

PRIMARY outcome

Timeframe: 1 year from time enrolled

Night time microfilarial counts at 1 year

Outcome measures

Measure	Standard Therapy Annual DEC/ALB n=13 Participants Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)	High Dose Annual DEC/ALB n=13 Participants Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)	High Dose Semiannual DEC/ALB n=13 Participants Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
Microfilarial Counts at 1 Year	0 MF/ML Interval 0.0 to 20.0	0 MF/ML Interval 0.0 to 12.0	0 MF/ML Interval 0.0 to 9.0

SECONDARY outcome

Timeframe: 2 years from the time enrolled.

Population: By 2 years, 4 subjects in High Dose Group lost to followup

Doppler detected worm nests at 2 years

Outcome measures

Measure	Standard Therapy Annual DEC/ALB n=13 Participants Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)	High Dose Annual DEC/ALB n=13 Participants Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)	High Dose Semiannual DEC/ALB n=10 Participants Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
Adult Worm Burdens at 2 Years	0 Number of nests Interval 0.0 to 0.0	0 Number of nests Interval 0.0 to 0.0	0 Number of nests Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 2 years from time enrolled

Population: By 2 years, 4 subjects in High Dose Group lost to followup

Night time microfilarial levels at 2 years

Outcome measures

Measure	Standard Therapy Annual DEC/ALB n=13 Participants Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)	High Dose Annual DEC/ALB n=13 Participants Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)	High Dose Semiannual DEC/ALB n=10 Participants Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
Microfilarial Levels at 2 Years	0 MF/ML Interval 0.0 to 0.0	0 MF/ML Interval 0.0 to 0.0	0 MF/ML Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 2 years

Population: By 2 years, 4 subjects in High Dose Group lost to followup

IgG4 antibodies directed against Brugia malayi antigen

Outcome measures

Measure	Standard Therapy Annual DEC/ALB n=13 Participants Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)	High Dose Annual DEC/ALB n=13 Participants Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)	High Dose Semiannual DEC/ALB n=10 Participants Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
Brugia Specific Immunoglobulin G4 (IgG4) Antibodies	150 ng/ml Interval 0.0 to 1000.0	224 ng/ml Interval 0.0 to 2100.0	128 ng/ml Interval 0.0 to 650.0

Adverse Events

Standard Therapy Annual DEC/ALB

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

High Dose Annual DEC/ALB

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

High Dose Semiannual DEC/AC=LB

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Standard Therapy Annual DEC/ALB n=13 participants at risk Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)	High Dose Annual DEC/ALB n=13 participants at risk Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)	High Dose Semiannual DEC/AC=LB n=14 participants at risk Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
Musculoskeletal and connective tissue disorders Myalgia	69.2% 9/13 • Number of events 9 • Every 6 months	61.5% 8/13 • Number of events 8 • Every 6 months	78.6% 11/14 • Number of events 11 • Every 6 months
Investigations Fever	38.5% 5/13 • Number of events 5 • Every 6 months	30.8% 4/13 • Number of events 4 • Every 6 months	28.6% 4/14 • Number of events 4 • Every 6 months
Gastrointestinal disorders Nausea/Vomiting	7.7% 1/13 • Number of events 1 • Every 6 months	7.7% 1/13 • Number of events 1 • Every 6 months	0.00% 0/14 • Every 6 months

Additional Information

Thomas B. Nutman

NIAID

Phone: 301-496-5398

Email: tnutman@niaid.nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place