Clinical trial NCT03352206: Prevalence Studies After Triple Drug Therapy for Lymphatic Filariasis
Official title: Community Studies to Monitor the Impact of Triple Drug Therapy Relative to Double Drug Therapy on Lymphatic Filariasis Infection Indicators
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphatic Filariases
Keywords: Mass drug administration
Effectiveness
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
name: Ministere de la Sante Publique et de la Population, Haiti
name: Indonesia University
name: Papua New Guinea Institute for Medical Research
First posted: 2017-11-24
Enrollment: 20092
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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).

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 unpublished data).1 Recently, large safety studies that treated more than 23,000 participants across four countries were conducted to determine if IDA was safe for use in mass drug administration (MDA) (DOLF Project, unpublished data).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

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with circulating filarial antigenemia (CFA) as measured by the Filaria Test Strip
timeFrame: One sample collected about 12 months after exposure to treatment
measure: Number of participants with IgG4 antifilarial antibodies in plasma
timeFrame: One sample collected about 12 months after exposure to treatment
measure: Number of participants with microfilaremia as measured with night blood smear testing
timeFrame: One sample collected about 12 months after exposure to treatment
Secondary outcomes:
measure: Community prevalence of microfilaremia as measured with night blood smear
timeFrame: One comparison about 12 months after exposure to treatment
measure: Community prevalence of circulating filarial antigen as measured with filarial test strip
timeFrame: One comparison about 12 months after exposure to treatment
measure: Prevalence of STH (hookworm, ascaris, trichuris and strongyloides) as measured by Kato-katz or PCR
timeFrame: One comparison about 12 months after exposure to treatment
Other outcomes:
Locations:
city: Suva
country: Fiji
facility: Ministry of Health and Medical Services
city: Port-au-Prince
country: Haiti
facility: Ministere de la Sante Publique et de la Population
city: Puducherry
country: India
facility: Vector Control Research Centre
city: Jakarta
country: Indonesia
facility: Universitas Indonesia
city: Madang
country: Papua New Guinea
facility: Papua New Guinea Institute for Medical Research
Study officials:
affiliation: Washington University School of Medicine
name: Gary Weil, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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. No abstract available.
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.
citation: 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.
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.
citation: 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.