Prevalence Studies After Triple Drug Therapy for Lymphatic Filariasis

December 30, 2020 updated by: Washington University School of Medicine

Community Studies to Monitor the Impact of Triple Drug Therapy Relative to Double Drug Therapy on Lymphatic Filariasis Infection Indicators

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 unpublished data).1 Recently, large safety studies that treated more than 23,000 participants across four countries were conducted to determine if IDA was safe for use in mass drug administration (MDA) (DOLF Project, unpublished data).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

Enrollment (Actual)

20092

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Fiji
      • Suva, Fiji
        • Ministry of Health and Medical Services
  • Haiti
      • Port-au-Prince, Haiti
        • Ministère de la Santé Publique et de la Population
  • India
      • Puducherry, India, 605006
        • Vector Control Research Centre
  • Indonesia
      • Jakarta, Indonesia
        • Universitas Indonesia
  • Papua New Guinea
      • Madang, Papua New Guinea
        • Papua New Guinea Institute for Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • 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 Names:
  • IDA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One sample collected about 12 months after exposure to treatment
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.
One sample collected about 12 months after exposure to treatment
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.
One sample collected about 12 months after exposure to treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One comparison about 12 months after exposure to treatment
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
One comparison about 12 months after exposure to treatment
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.
One comparison about 12 months after exposure to treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Indonesia University
Case Western Reserve University
Ministere de la Sante Publique et de la Population, Haiti
Papua New Guinea Institute for Medical Research

Investigators

  • Principal Investigator: Gary Weil, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2017

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

November 20, 2017

First Submitted That Met QC Criteria

November 20, 2017

First Posted (Actual)

November 24, 2017

Study Record Updates

Last Update Posted (Actual)

December 31, 2020

Last Update Submitted That Met QC Criteria

December 30, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201710040

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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