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Prevalence Studies After Triple Drug Therapy for Lymphatic Filariasis

NCT ID: NCT03352206

Last Updated: 2020-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20092 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-18

Study Completion Date

2019-11-01

Brief Summary

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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

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 unpublished data).1 Recently, large safety studies that treated more than 23,000 participants across four countries were conducted to determine if IDA was safe for use in mass drug administration (MDA) (DOLF Project, unpublished data).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

Conditions

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Lymphatic Filariases

Keywords

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Mass drug administration Effectiveness

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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."

2 drug dose - DA

Intervention Type DRUG

Lymphatic Filariasis Mass Drug Administration (MDA) with the currently used standard of care combination drug therapy of diethylcarbamazine and albendazole (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."

3 drug dose - IDA

Intervention Type DRUG

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

Interventions

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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)

Intervention Type DRUG

3 drug dose - IDA

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

Intervention Type DRUG

Other Intervention Names

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DA IDA

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Case Western Reserve University

OTHER

Sponsor Role collaborator

Ministere de la Sante Publique et de la Population, Haiti

UNKNOWN

Sponsor Role collaborator

Indonesia University

OTHER

Sponsor Role collaborator

Papua New Guinea Institute for Medical Research

UNKNOWN

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gary Weil, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Ministry of Health and Medical Services

Suva, , Fiji

Site Status

Ministere de la Sante Publique et de la Population

Port-au-Prince, , Haiti

Site Status

Vector Control Research Centre

Puducherry, , India

Site Status

Universitas Indonesia

Jakarta, , Indonesia

Site Status

Papua New Guinea Institute for Medical Research

Madang, , Papua New Guinea

Site Status

Countries

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Fiji Haiti India Indonesia Papua New Guinea

References

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Thomsen EK, Sanuku N, Baea M, Satofan S, Maki E, Lombore B, Schmidt MS, Siba PM, Weil GJ, Kazura JW, Fleckenstein LL, King CL. Efficacy, Safety, and Pharmacokinetics of Coadministered Diethylcarbamazine, Albendazole, and Ivermectin for Treatment of Bancroftian Filariasis. Clin Infect Dis. 2016 Feb 1;62(3):334-341. doi: 10.1093/cid/civ882. Epub 2015 Oct 20.

Reference Type BACKGROUND
PMID: 26486704 (View on PubMed)

Hooper PJ, Chu BK, Mikhailov A, Ottesen EA, Bradley M. Assessing progress in reducing the at-risk population after 13 years of the global programme to eliminate lymphatic filariasis. PLoS Negl Trop Dis. 2014 Nov 20;8(11):e3333. doi: 10.1371/journal.pntd.0003333. eCollection 2014 Nov.

Reference Type BACKGROUND
PMID: 25411843 (View on PubMed)

Ichimori K, King JD, Engels D, Yajima A, Mikhailov A, Lammie P, Ottesen EA. Global programme to eliminate lymphatic filariasis: the processes underlying programme success. PLoS Negl Trop Dis. 2014 Dec 11;8(12):e3328. doi: 10.1371/journal.pntd.0003328. eCollection 2014 Dec. No abstract available.

Reference Type BACKGROUND
PMID: 25502758 (View on PubMed)

Irvine MA, Stolk WA, Smith ME, Subramanian S, Singh BK, Weil GJ, Michael E, Hollingsworth TD. Effectiveness of a triple-drug regimen for global elimination of lymphatic filariasis: a modelling study. Lancet Infect Dis. 2017 Apr;17(4):451-458. doi: 10.1016/S1473-3099(16)30467-4. Epub 2016 Dec 22.

Reference Type BACKGROUND
PMID: 28012943 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

Laman M, Tavul L, Karl S, Kotty B, Kerry Z, Kumai S, Samuel A, Lorry L, Timinao L, Howard SC, Makita L, John L, Bieb S, Wangi J, Albert JM, Payne M, Weil GJ, Tisch DJ, Bjerum CM, Robinson LJ, King CL. Mass drug administration of ivermectin, diethylcarbamazine, plus albendazole compared with diethylcarbamazine plus albendazole for reduction of lymphatic filariasis endemicity in Papua New Guinea: a cluster-randomised trial. Lancet Infect Dis. 2022 Aug;22(8):1200-1209. doi: 10.1016/S1473-3099(22)00026-3. Epub 2022 May 6.

Reference Type DERIVED
PMID: 35533701 (View on PubMed)

Other Identifiers

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201710040

Identifier Type: -

Identifier Source: org_study_id