Prevalence Studies After Triple Drug Therapy for Lymphatic Filariasis

NCT03352206 | Completed

• 1 other identifier: 201710040
• Study Type: observational
• Target: 20,092
• Locations: 5 countries
• Sites: 5

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).

Conditions

Lymphatic Filariases

Keywords

Mass drug administration; Effectiveness

Outcome Measures

Primary Outcomes (3)

• Number of participants with circulating filarial antigenemia (CFA) as measured by the Filaria Test Strip

  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

  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

  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 Outcomes (3)

• Community prevalence of microfilaremia as measured with night blood smear

  One comparison about 12 months after exposure to treatment

• Community prevalence of circulating filarial antigen as measured with filarial test strip

  One comparison about 12 months after exposure to treatment

• Prevalence of STH (hookworm, ascaris, trichuris and strongyloides) as measured by Kato-katz or PCR

  One comparison about 12 months after exposure to treatment

Study Arms (2)

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

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

Interventions

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)

Also known as: DA

2-Drug Treated Communities

3 drug dose - IDA DRUG

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

Also known as: IDA

3-Drug Treated Communities

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Case Western Reserve University: collaborator
• Ministere de la Sante Publique et de la Population, Haiti: collaborator
• Indonesia University: collaborator
• Papua New Guinea Institute for Medical Research: collaborator

Study Sites (5)

Ministry of Health and Medical Services

Suva, Fiji

Location

Ministere de la Sante Publique et de la Population

Port-au-Prince, Haiti

Location

Vector Control Research Centre

Puducherry, 605006, India

Location

Universitas Indonesia

Jakarta, Indonesia

Location

Papua New Guinea Institute for Medical Research

Madang, Papua New Guinea

Location

Related Publications (7)

• 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.

  PMID: 26486704 BACKGROUND

• 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.

  PMID: 25411843 BACKGROUND

• 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.

  PMID: 25502758 BACKGROUND

• 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.

  PMID: 28012943 BACKGROUND

• 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.

  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.

  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.

  PMID: 35533701 DERIVED

MeSH Terms

Conditions

Elephantiasis, Filarial

Condition Hierarchy (Ancestors)

Filariasis; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Gary Weil, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 24, 2017
• Study Start: October 18, 2017
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: December 31, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share

Locations

PA (1); FI (1); ID (1); HA (1); IN (1)