Effect of Albendazole Dose on Treatment of Lymphatic Filariasis

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

  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
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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.
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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
Overall Participants Analyzed; [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 ]

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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  Serious Adverse Events

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  Other Adverse Events

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  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.

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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:

Edwards G, Awadzi K, Breckenridge AM, Gilles HM, Orme ML, Ward SA. Diethylcarbamazine disposition in patients with onchocerciasis. Clin Pharmacol Ther. 1981 Oct;30(4):551-7.

Taylor HR, Greene BM. Ocular changes with oral and transepidermal diethylcarbamazine therapy of onchocerciasis. Br J Ophthalmol. 1981 Jul;65(7):494-502.

Partono F, Purnomo, Oemijati S, Soewarta A. The long term effects of repeated diethylcarbamazine administration with special reference to microfilaraemia and elephantiasis. Acta Trop. 1981 Sep;38(3):217-25.

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