A Phase 4 interventional study of 400 μg/kg Ivermectin + 400 mg Albendazole in Lymphatic Filariasis and Helminth Infection, sponsored by Noguchi Memorial Institute for Medical Research. Completed at 1 site in Ghana. Open to participants aged 5 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-26.
Sponsored by Noguchi Memorial Institute for Medical Research · Phase 4, Interventional, and Treatment
The Global Program for the Elimination of Lymphatic Filariasis (GPELF) has been in operation sing the year 2000, with the aim of eliminating the disease by the year 2020, following 5-6 rounds of effective annual Mass Drug Administration (MDA). The treatment regimen is Ivermectin (IVM) in combination with Diethylcarbamazine (DEC) or Albendazole (ALB). In Ghana, MDA has been undertaken since 2001. While the disease has been eliminated in many areas, transmission has persisted in some implementation units that had experienced 15 or more rounds of MDA. Alternative intervention strategies, including twice yearly MDA and sleeping under insecticidal nets have significantly accelerated transmission interruption in some settings of high transmission intensity. Thus, it is evident that new intervention strategies could eliminate residual infection in areas of persistent transmission and speed up the LF elimination process. This study therefore seeks to test the hypothesis that biannual treatment of LF endemic communities will accelerate interruption of LF transmission.
Two cluster randomized trials will be implemented in LF endemic communities in Ghana. The interventions will be yearly or twice-yearly MDA delivered to entire endemic communities. Allocation to study group will be by clusters identified using the prevalence of LF. Clusters will be randomised to one of two groups: receiving either (1) annual treatment with IVM+ALB; (2) annual MDA with IVM +ALB, followed by an additional MDA 6 months later. The primary outcome measure is the prevalence of LF infection, assessed by four cross-sectional surveys. Entomological assessments will also be undertaken to evaluate the transmission intensity of the disease in the study clusters. Costs and cost-effectiveness will be evaluated. Among a random subsample of participants, microfilaria prevalence will be assessed longitudinally. A nested process evaluation, using semi-structured interviews, focus group discussions and a stakeholder analysis, will investigate the community acceptability, feasibility and scale-up of each delivery system.
42 studies on the registry are indexed under Elephantiasis, Filarial; 5 are open to participants now.
This study's enrollment of 1,462 is above the median of 1,000 across 27 interventional studies indexed under Elephantiasis, Filarial.
Browse Elephantiasis, Filarial studies →Noguchi Memorial Institute for Medical Research is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
400 μg/kg Ivermectin + 400 mg Albendazole Tablets given every year for 2 years
Drug: 400 μg/kg Ivermectin + 400 mg Albendazole
400 μg/kg Ivermectin + 400 mg Albendazole, Tablets given every 6 months for 2 years
Drug: 400 μg/kg Ivermectin + 400 mg Albendazole
400ug/Kg, tablet, given orally once or twice a year.
Also known as: Mectizan, Stromectol
Change from baseline prevalence of Lymphatic Filariasis at 24 months
The primary outcome, the prevalence of LF infection, will be measured through cross-sectional parasitological surveys conducted at baseline and at 24 months. The timing of the final follow-up survey will take into account differences in time since treatment of the annual and biannual treatment groups at 24 months
Time frame: 0 and 24 months
Longitudinal assessment of transmission dynamics of Lymphatic Filariasis for modelling the impact of treatment
For the secondary outcome, a subsample of individuals from the clusters in each of the study groups will be followed longitudinally for two and half years, in order to better understand the transmission dynamics of LF and to estimate key parameters for mathematical modelling of transmission dynamics and treatment impact.
Time frame: 0, 12, 24, 30 months
Evaluation of community acceptability of twice-yearly treatment, through questionnaires and focus group discussions
A process evaluation, using semi-structured interviews, focus group discussions (FGDs) and a stakeholder analysis, will investigate the community acceptability of the twice-yearly drug administration.
Time frame: 24 months
Feasibility of scale-up of twice-yearly treatment, through questionnaires and focus group discussions
A process evaluation, using semi-structured interviews, focus group discussions (FGDs) and a stakeholder analysis, will investigate the feasibility of scaling up the twice-yearly drug administration.
Time frame: 24 months
Plan to share: No — IPD will not be shared publicly. Researchers interested in the data can contact the principal investigator directly. No personal identifying information will be shared.
Ran from May 2017 to primary completion in Dec 2019, 30 months.
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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Noguchi Memorial Institute for Medical Research