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Trial record 3 of 38 for:    "Elephantiasis" | "Anthelmintics"

Prevalence Studies After Triple Drug Therapy for Lymphatic Filariasis

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ClinicalTrials.gov Identifier: NCT03352206
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : September 30, 2019
Sponsor:
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

Tracking Information
First Submitted Date November 20, 2017
First Posted Date November 24, 2017
Last Update Posted Date September 30, 2019
Actual Study Start Date January 1, 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 20, 2017)
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03352206 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 20, 2017)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevalence Studies After Triple Drug Therapy for Lymphatic Filariasis
Official Title Community Studies to Monitor the Impact of Triple Drug Therapy Relative to Double Drug Therapy on Lymphatic Filariasis Infection Indicators
Brief Summary 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).
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Lymphatic Filariases
Intervention
  • 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
  • Drug: 3 drug dose - IDA
    Lymphatic Filariasis Mass Drug Administration (MDA) with triple drug therapy of ivermectin, diethylcarbamazine, and albendazole (IDA)
    Other Name: IDA
Study Groups/Cohorts
  • 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."
    Intervention: Drug: 2 drug dose - 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."
    Intervention: Drug: 3 drug dose - IDA
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 20, 2017)
22500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Teresa Tufte, MPH 314-747-5758 teresa.tufte@wustl.edu
Listed Location Countries Fiji,   Haiti,   India,   Indonesia,   Papua New Guinea
Removed Location Countries  
 
Administrative Information
NCT Number NCT03352206
Other Study ID Numbers 201710040
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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.
Responsible Party Washington University School of Medicine
Study Sponsor Washington University School of Medicine
Collaborators
  • 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
PRS Account Washington University School of Medicine
Verification Date September 2019