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Trial record 1 of 2 for:    "Onchocerciasis" | "Diethylcarbamazine"
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Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis (DOLF-Indo)

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ClinicalTrials.gov Identifier: NCT01905423
Recruitment Status : Completed
First Posted : July 23, 2013
Results First Posted : October 16, 2017
Last Update Posted : October 16, 2017
Sponsor:
Information provided by (Responsible Party):
Gary Weil, MD, Washington University School of Medicine

Brief Summary:

Approximately 3,500 people will participate per year. The study population will include females and males over 5 years of age who live in filariasis endemic areas. The study will be performed in Indonesia in B. timori and W. bancrofti endemic areas over a period of 4 years. Participants will be studied only once in cross-sectional surveys. Some subjects may be included in more than one annual population survey, but this is not a longitudinal study. Purpose of the study is to evaluate different mass drug administration (MDA) regimens for lymphatic filariasis and also to study the impact of MDA on soil transmitted helminth infections (STH). MDA will administered by others (e.g., Ministry of Health). Results of this study may enhance efforts to control and eliminate these important neglected tropical diseases.

The investigators will test the hypothesis that accelerated mass drug administration will be superior to annual MDA for elimination of lymphatic filariasis and for control of soil transmitted helminth infections (STH):

  1. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of lymphatic filariasis (LF).
  2. Study the impact of annual vs. semiannual MDA on soil transmitted helminth (STH) infection in these populations.

Condition or disease Intervention/treatment
Lymphatic Filariasis Soil Transmitted Helminth Infections Drug: Albendazole and diethylcarbamazine

Detailed Description:

Lymphatic filariasis (LF) is a deforming and disabling infectious disease that causes elephantiasis and genital deformity (especially hydroceles). The infection affects some 120 million people in 81 countries in tropical and subtropical regions with well over 1 billion people at risk of acquiring the disease. LF is caused by Wuchereria bancrofti and Brugia spp. (B. malayi and B.timori), nematode parasites that are transmitted by mosquitoes. This study is based on the assumption that currently used mass drug administration (MDA) regimens and schedules are not optimal for achieving elimination of LF. These regimens (either annual Albendazole (Alb) 400 mg plus diethylcarbamazine (DEC) 6 mg/kg or Alb 400 mg plus ivermectin (Iver) 200 µg/kg for LF) were developed more than 10 years ago.

Drugs used for LF MDA are also active against soil transmitted helminth infections (STH, e.g., Ascaris, Hookworm, and Trichuris). De-worming campaigns using anthelminthics usually target special groups of the population, such as schoolchildren, and have limited impact on the transmission. Treatment of the total population and semiannual treatments may reduce re-infection considerably and will most likely lead to reduced infection densities and infection prevalences. Suppression of STH is an important ancillary benefit of MDA programs for filarial infections.

Purpose: The study aims to compare the effectiveness once yearly (1X) versus twice yearly (2X) mass drug administration (MDA) for the elimination of lymphatic filariasis and for control of soil-transmitted helminths (intestinal parasites) in large populations. Mass drug administration will be provided by the Indonesia Ministry of Health. This project will assess the impact of the public health program.

Procedures: Study procedures include collection of finger prick blood that will be tested for microfilaremia and for serology testing (antigenemia and antibody testing). Stool samples will be collected to detect STH infections. All assays will be performed in Indonesia (filarial serology tests, blood smears for detection of microfilariae (MF), and stool examinations for detection of worm eggs).

Washington University researchers developed the protocol, will provide training and guidance to Indonesian researchers, and work with them to analyze the data. Indonesian researchers will consent the participants, obtain stool and blood specimens, perform laboratory tests on the specimens, and enter data on participants and lab results.


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Study Type : Observational
Actual Enrollment : 19308 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis
Study Start Date : May 2011
Actual Primary Completion Date : March 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Albendazole

Group/Cohort Intervention/treatment
Annual MDA treated Group
This group will receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program.
Drug: Albendazole and diethylcarbamazine
Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly
Other Names:
  • Albenza (Albendazole, also known as ALB)
  • Diethylcarbamazine, Also known as DEC, (N, N-diethyl-4-methyl-1-piperazine carboxamide dihydrogen citrate). ATC Code: P02CB02 QP52AH02

Semiannual MDA treated group
This group will receive semiannual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health.
Drug: Albendazole and diethylcarbamazine
Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly
Other Names:
  • Albenza (Albendazole, also known as ALB)
  • Diethylcarbamazine, Also known as DEC, (N, N-diethyl-4-methyl-1-piperazine carboxamide dihydrogen citrate). ATC Code: P02CB02 QP52AH02




Primary Outcome Measures :
  1. Microfilaria Prevalence in Blood by Microscopy [ Time Frame: 4 years ]
    Microfilariae (filarial parasites) will be detected in blood smears by microscopy. Samples will be collected in annual community surveys. Microfilaremia is a categorical variable (positive or negative). Prevalence rates are expressed as % positive.


Secondary Outcome Measures :
  1. Filarial Antigenemia in Blood and Worm Parasite Eggs in Stool by Microscopy [ Time Frame: 4 years ]
    Secondary outcomes for the study include prevalence of filarial antigenemia (detected with the Binax Filariasis Now card test) and prevalence of worm eggs in stool detected by the Kato-Katz test. Both of these prevalence outcomes are qualitative with no units of measure (positive or negative). Prevalence date are expressed as % positive. Other secondary outcome measures will be intensity of parasite infections (microfilariae per ml of blood and the number of worm eggs per gram of stool).


Biospecimen Retention:   Samples Without DNA

Study procedures include collection of finger prick blood that will be tested for microfilaremia and for serology testing (antigenemia and antibody testing). We will also collect stool samples to detect STH infections.

All assays will be performed in Indonesia (filarial serology tests, MF smears, stool examinations).



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study populations are people who live in areas of Indonesia that are endemic for lymphatic filariasis.
Criteria

Inclusion Criteria:

  • Areas should be endemic for filariasis and have limited or no prior experience with MDA. Males and Females greater than or equal to 5 years of age.

Exclusion Criteria:

  • Children less than 5 years of age.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905423


Locations
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Indonesia
University of Indonesia, Department of Parasitology
Jakarta, Java, Indonesia, 10430
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Peter U Fischer, Ph.D. Washington University School of Medicine
Principal Investigator: Gary J Weil, MD Washington University School of Medicine
Study Director: Taniawati Supali, Ph.D. Indonesia University

Additional Information:
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Responsible Party: Gary Weil, MD, Professor of Medicine/ Microbiology, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01905423     History of Changes
Other Study ID Numbers: 201103313
First Posted: July 23, 2013    Key Record Dates
Results First Posted: October 16, 2017
Last Update Posted: October 16, 2017
Last Verified: May 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gary Weil, MD, Washington University School of Medicine:
Filariasis
Albendazole
Diethylcarbamazine
STH Soil Transmitted Helminths
MDA Mass Drug Administration

Additional relevant MeSH terms:
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Onchocerciasis
Diethylcarbamazine
Filariasis
Elephantiasis
Elephantiasis, Filarial
Helminthiasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Parasitic Diseases
Lymphedema
Lymphatic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Albendazole
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Filaricides
Antinematodal Agents
Lipoxygenase Inhibitors