Twice Yearly Treatment for the Control of LF

NCT03036059 | Completed Phase 4

• 1 other identifier: TMA 2015 CDF - 976
• Study Type: interventional
• Target: 1,462
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphatic Filariasis; Helminth Infection

Keywords

Twice a year treatment; Biannual treatment; Wuchereria bancrofti

Outcome Measures

Primary Outcomes (1)

• 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

  0 and 24 months

Secondary Outcomes (3)

• Longitudinal assessment of transmission dynamics of Lymphatic Filariasis for modelling the impact of treatment

  0, 12, 24, 30 months

• Evaluation of community acceptability of twice-yearly treatment, through questionnaires and focus group discussions

  24 months

• Feasibility of scale-up of twice-yearly treatment, through questionnaires and focus group discussions

  24 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

400 μg/kg Ivermectin + 400 mg Albendazole Tablets given every year for 2 years

Drug: 400 μg/kg Ivermectin + 400 mg Albendazole

Expanded frequency group

EXPERIMENTAL

400 μg/kg Ivermectin + 400 mg Albendazole, Tablets given every 6 months for 2 years

Drug: 400 μg/kg Ivermectin + 400 mg Albendazole

Interventions

400 μg/kg Ivermectin + 400 mg Albendazole DRUG

400ug/Kg, tablet, given orally once or twice a year.

Also known as: Mectizan, Stromectol

Control group; Expanded frequency group

Eligibility Criteria

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

You may qualify if:

• Residency in the disease endemic community for at least 12 months
• Willingness to provide informed consent/assent
• Willingness to donate blood (per the protocol)

You may not qualify if:

• Recent residents (\<12 months)
• Inability to give informed consent
• Pregnant and lactating women
• Children below the age of 5.

Sponsors & Collaborators

• Noguchi Memorial Institute for Medical Research: lead
• Ghana Health Services: collaborator

Study Sites (1)

Noguchi Memorial Institute for Medical Research

Legon-Accra, Ghana

Location

Related Publications (1)

• de Souza DK, Ahorlu CS, Adu-Amankwah S, Otchere J, Mensah SK, Larbi IA, Mensah GE, Biritwum NK, Boakye DA. Community-based trial of annual versus biannual single-dose ivermectin plus albendazole against Wuchereria bancrofti infection in human and mosquito populations: study protocol for a cluster randomised controlled trial. Trials. 2017 Oct 2;18(1):448. doi: 10.1186/s13063-017-2196-9.

  PMID: 28969715 DERIVED

MeSH Terms

Conditions

Elephantiasis, Filarial; Trematode Infections

Interventions

Ivermectin; Albendazole

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

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Dziedzom K de Souza, PhD

  Noguchi Memorial Institute for Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: January 30, 2017
• Study Start: May 19, 2017
• Primary Completion: December 8, 2019
• Study Completion: December 8, 2019
• Last Updated: February 26, 2020

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1)