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Completed

NCT Number: NCT03352206

Prevalence Studies After Triple Drug Therapy for Lymphatic Filariasis

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).

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Key information

Conditions

Lymphatic Filariases Elephantiasis, Filarial Filariasis Helminthiasis Hemic and Lymphatic Diseases Infections Lymphatic Diseases Lymphedema Mosquito-Borne Diseases Nematode Infections Parasitic Diseases Secernentea Infections Spirurida Infections Vector Borne Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ministry of Health and Medical Services, Suva, Fiji

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About this study

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 unpublished data).1 Recently, large safety studies that treated more than 23,000 participants across four countries were conducted to determine if IDA was safe for use in mass drug administration (MDA) (DOLF Project, unpublished data).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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2 drug dose - DA

Drug

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 dose - IDA

Drug

Lymphatic Filariasis Mass Drug Administration (MDA) with triple drug therapy of ivermectin, diethylcarbamazine, and albendazole (IDA)

Other names: IDA

Primary outcomes

  1. 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.

  2. 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.

  3. 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 outcomes

  1. 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

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 24, 2017
Registry last updated
Dec 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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