Twice Yearly Treatment for the Control of LF

Noguchi Memorial Institute for Medical Research

Status and phase: Completed; Phase 4

Conditions: Lymphatic Filariasis; Helminth Infection

Treatments: Drug: 400 μg/kg Ivermectin + 400 mg Albendazole

Study type: Interventional

Funder types: Other

Identifiers

NCT03036059

TMA 2015 CDF - 976

Details and patient eligibility

About

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.

Enrollment: 1,462 patients

Sex: All

Ages: 5+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,462 participants in 2 patient groups

Control group

Active Comparator group

Description:

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

Treatment:

Drug: 400 μg/kg Ivermectin + 400 mg Albendazole

Expanded frequency group

Experimental group

Description:

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

Treatment:

Drug: 400 μg/kg Ivermectin + 400 mg Albendazole