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Prevalence Studies After Triple Drug Therapy for Lymphatic Filariasis

This study is currently recruiting participants.
Verified November 2017 by Washington University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT03352206
First Posted: November 24, 2017
Last Update Posted: December 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Case Western Reserve University
Ministere de la Sante Publique et de la Population, Haiti
Indonesia University
Papua New Guinea Institute for Medical Research
Information provided by (Responsible Party):
Washington University School of Medicine
  Purpose
This study will assess the impact of 2-drug (DA) or 3-drug (IDA) regimens on lymphatic filariasis infection parameters in communities. Parameters measured will include: circulating filarial antigenemia (CFA) assessed with the Filariasis Test Strip (FTS), antifilarial antibodies tested with plasma and microfilaremia (assessed by night blood smears and microscopy).

Condition Intervention
Lymphatic Filariases Drug: 2 drug dose - DA Drug: 3 drug dose - IDA

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Community Studies to Monitor the Impact of Triple Drug Therapy Relative to Double Drug Therapy on Lymphatic Filariasis Infection Indicators

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Number of participants with circulating filarial antigenemia (CFA) as measured by the Filaria Test Strip [ Time Frame: One sample collected about 12 months after exposure to treatment ]
    To assess the impact of DA vs. IDA mass drug administration in community settings participants will be tested using the filaria test strip (FTS) which detects circulating filarial antigen.

  • Number of participants with IgG4 antifilarial antibodies in plasma [ Time Frame: One sample collected about 12 months after exposure to treatment ]
    To assess the impact of DA vs. IDA mass drug administration in community settings participant's dried blood spot specimens will be tested using a commercially available antibody test.

  • Number of participants with microfilaremia as measured with night blood smear testing [ Time Frame: One sample collected about 12 months after exposure to treatment ]
    To assess the impact of DA vs. IDA mass drug administration in community settings participants with positive FTS will be tested for presence of microfilaria detected by thick blood smear using 60 microliters (ul) from finger prick blood collected at night.


Secondary Outcome Measures:
  • Community prevalence of microfilaremia as measured with night blood smear [ Time Frame: One comparison about 12 months after exposure to treatment ]
    Community prevalence of microfilaremia will be compared between the two cohorts to identify any difference of the impact of mass drug administration with IDA or DA

  • Community prevalence of circulating filarial antigen as measured with filarial test strip [ Time Frame: One comparison about 12 months after exposure to treatment ]
    Community prevalence of circulating filarial antigen will be compared between the two cohorts to identify any difference of the impact of mass drug administration with IDA or DA

  • Prevalence of STH (hookworm, ascaris, trichuris and strongyloides) as measured by Kato-katz or PCR [ Time Frame: One comparison about 12 months after exposure to treatment ]
    Some sites will include stool sample collections to compare the impact of MDA with IDA or DA on soil transmitted helminth (STH) infection parameters in communities. Stool samples will be analyzed using Kath-katz method, as well as PCR.


Estimated Enrollment: 22500
Actual Study Start Date: September 1, 2017
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
2-Drug Treated Communities
Communities who were treated with diethylcarbamazine and albendazole (DA) mass drug administration during the safety study entitled "Community Based Safety Study of 2-drug (DA) versus 3-drug (IDA) Therapy for Lymphatic Filariasis."
Drug: 2 drug dose - DA
Lymphatic Filariasis Mass Drug Administration (MDA) with the currently used standard of care combination drug therapy of diethylcarbamazine and albendazole (DA)
Other Name: DA
3-Drug Treated Communities
Communities who were treated with ivermectin, diethylcarbamazine and albendazole (IDA) mass drug administration during the safety study entitled "Community Based Safety Study of 2-drug (DA) versus 3-drug (IDA) Therapy for Lymphatic Filariasis."
Drug: 3 drug dose - IDA
Lymphatic Filariasis Mass Drug Administration (MDA) with triple drug therapy of ivermectin, diethylcarbamazine, and albendazole (IDA)
Other Name: IDA

Detailed Description:
Results from clinical trials in Papua New Guinea and Cote d'Ivoire have shown that a single dose of three drugs (ivermectin, diethylcarbamazine, and albendazole [IDA]) was superior to standard two drug therapy (diethylcarbamazine and albendazole [DA]) in clearing W. bancrofti microfilaremia (MF) (King et al. unpublished data).1 Recently, large safety studies that treated more than 23,000 participants across four countries were conducted to determine if IDA was safe for use in mass drug administration (MDA) (DOLF Project, unpublished data). Currently, there is no information about what community indicators of infection look like following shorter IDA programs. It is possible that current WHO guidelines for stopping MDA need to be modified for MDA programs that use IDA. Observing the levels of infection indicators in a community following treatment with IDA will provide important information to the GPELF if IDA is recommended for use in MDA programs. There is an opportunity to study communities that were treated with IDA during the "Community Based Safety Study of 2-drug (Diethylcarbamazine and Albendazole) versus 3-drug (Ivermectin, Diethylcarbamazine and Albendazole) Therapy for Lymphatic Filariasis". Communities in this study were randomly assigned to receive IDA or DA treatment. A large percentage of individuals in these communities participated in the study thereby approximating a mass distribution of the treatments. By surveying these communities 12 months following their initial treatment the investigators will be able to better understand and compare the impact of MDA with IDA or DA on LF infection parameters at the level of communities.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All eligible individuals who reside in the communities where the "Community Based Safety Study of 2-drug (Diethylcarbamazine and Albendazole) versus 3-drug (Ivermectin, Diethylcarbamazine and Albendazole) Therapy for Lymphatic Filariasis" was conducted.
Criteria

Inclusion Criteria:

  • Age ≥ 5 years (males and females)
  • Able to provide informed consent, or parental/guardian consent for young children, and assent for older children

Exclusion Criteria:

  • Unable or unwilling to provide informed consent or (for minors) lacking parental/guardian consent to participate in the study
  Contacts and Locations
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): NCT03352206


Contacts
Contact: Joshua Bogus, MPH 314-747-5758 jbogus@dom.wustl.edu

Locations
Fiji
Ministry of Health and Medical Services Not yet recruiting
Suva, Fiji
Contact: Josaia Samuela, MBBS, MPH    679-3320844 ext 221    josaia.samuela@health.gov.fj   
Principal Investigator: Andrew Steer, PhD         
Sub-Investigator: Myra Hardy, MD         
Principal Investigator: Josaia Samuela, MBBS MPH         
Haiti
Ministere de la Sante Publique et de la Population Not yet recruiting
Port-au-Prince, Haiti
Contact: Jean Frantz Lemoine, MD MPH    +1 509 3744-8755    tileum@hotmail.com   
Principal Investigator: Christine Dubray, MD MSc         
Principal Investigator: Jean Frantz Lemoine, MD MPH         
India
Vector Control Research Centre Recruiting
Puducherry, India, 605006
Contact: Purushothaman Jambulingam, MD    +91 413 2272422    pcsaja@yahoo.co.uk   
Principal Investigator: Purushothaman Jambulingam, MD         
Indonesia
Universitas Indonesia Active, not recruiting
Jakarta, Indonesia
Papua New Guinea
Papua New Guinea Institute for Medical Research Not yet recruiting
Madang, Papua New Guinea
Contact: Leanne Robinson, PhD, MPH    675 422 2909    robinson@wehi.EDU.AU   
Contact: Peter Siba, PhD    675 532 2800    peter.siba@pngimr.org.pg   
Principal Investigator: Christopher King, MD PhD         
Principal Investigator: Leanne Robinson, PhD MPH         
Principal Investigator: Peter Siba, PhD         
Sponsors and Collaborators
Washington University School of Medicine
Case Western Reserve University
Ministere de la Sante Publique et de la Population, Haiti
Indonesia University
Papua New Guinea Institute for Medical Research
Investigators
Principal Investigator: Gary Weil, MD Washington University School of Medicine
  More Information

Publications:
World Health Organization. Monitoring and Epidemiological Assessment of Mass Drug Administration in Global Programme to Eliminate Lymphatic Filariasis: A Manual for National Elimination Programmes. Geneva: World Health Organization; 2011. http://www.who.int/lymphatic_filariasis/resources/9789241501484/en/. Accessed October 11, 2017.
World Health Organization. Assessing the epidmiology of soil-transmitted helminths during a transmission assessment survey in the global programme for the elimination of lymphatic filariasis. 2015. http://apps.who.int/iris/bitstream/10665/153240/1/9789241508384_eng.pdf. Accessed October 12, 2017.

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03352206     History of Changes
Other Study ID Numbers: 201710040
First Submitted: November 20, 2017
First Posted: November 24, 2017
Last Update Posted: December 1, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Datasets used for published results will be shared publically through a journal or other open source data repository so that the broader scientific community can access it. Only de-identified data will be shared publicly.
URL: http://

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

Keywords provided by Washington University School of Medicine:
Mass drug administration
Effectiveness

Additional relevant MeSH terms:
Filariasis
Elephantiasis
Elephantiasis, Filarial
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Lymphedema
Lymphatic Diseases
Albendazole
Diethylcarbamazine
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
Enzyme Inhibitors