Prevalence Studies After Triple Drug Therapy for Lymphatic Filariasis

Lymphatic Filariases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03352206
• Other study ID #: 201710040
• Status: Completed
• Start date: October 18, 2017
• Est. completion date: November 1, 2019

Study information

• Verified date: December 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 unpublished data).1 Recently, large safety studies that treated more than 23,000 participants across four countries were conducted to determine if IDA was safe for use in mass drug administration (MDA) (DOLF Project, unpublished data).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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20092
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Fiji	Ministry of Health and Medical Services	Suva
Haiti	Ministere de la Sante Publique et de la Population	Port-au-Prince
India	Vector Control Research Centre	Puducherry
Indonesia	Universitas Indonesia	Jakarta
Papua New Guinea	Papua New Guinea Institute for Medical Research	Madang

Sponsors (5)

Lead Sponsor	Collaborator
Washington University School of Medicine	Case Western Reserve University, Indonesia University, Ministere de la Sante Publique et de la Population, Haiti, Papua New Guinea Institute for Medical Research

Countries where clinical trial is conducted

Fiji,  Haiti,  India,  Indonesia,  Papua New Guinea, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Community prevalence of microfilaremia as measured with night blood smear	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
Secondary	Community prevalence of circulating filarial antigen as measured with filarial test strip	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
Secondary	Prevalence of STH (hookworm, ascaris, trichuris and strongyloides) as measured by Kato-katz or PCR	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