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Trial record 51 of 106 for:    IVERMECTIN

Twice Yearly Treatment for the Control of LF

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ClinicalTrials.gov Identifier: NCT03036059
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : March 30, 2018
Sponsor:
Collaborator:
Ghana Health Services
Information provided by (Responsible Party):
Noguchi Memorial Institute for Medical Research

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.


Condition or disease Intervention/treatment Phase
Lymphatic Filariasis Helminth Infection Drug: 400 μg/kg Ivermectin + 400 mg Albendazole Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: Cluster Randomized Community-based Trial of Annual Versus Biannual Single-dose Ivermectin Plus Albendazole Against Wuchereria Bancrofti Infection in Human and Mosquito Populations
Actual Study Start Date : May 19, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control group
400 μg/kg Ivermectin + 400 mg Albendazole Tablets given every year for 2 years
Drug: 400 μg/kg Ivermectin + 400 mg Albendazole
400ug/Kg, tablet, given orally once or twice a year.
Other Name: Mectizan, Stromectol

Experimental: Expanded frequency group
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.
Other Name: Mectizan, Stromectol




Primary Outcome Measures :
  1. Change from baseline prevalence of Lymphatic Filariasis at 24 months [ Time Frame: 0 and 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


Secondary Outcome Measures :
  1. Longitudinal assessment of transmission dynamics of Lymphatic Filariasis for modelling the impact of treatment [ Time Frame: 0, 12, 24, 30 months ]
    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.

  2. Evaluation of community acceptability of twice-yearly treatment, through questionnaires and focus group discussions [ Time Frame: 24 months ]
    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.

  3. Feasibility of scale-up of twice-yearly treatment, through questionnaires and focus group discussions [ Time Frame: 24 months ]
    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.



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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036059


Contacts
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Contact: Susan Adu-Amankwah, BPharm, MPH +233302501178 sadu-amankwah@noguchi.ug.edu.gh
Contact: Collins Ahorlu, PhD +233268195705 cahorlu@noguchi.ug.edu.gh

Locations
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Ghana
Noguchi Memorial Institute for Medical Research Recruiting
Legon-Accra, Ghana
Contact: Dziedzom K. de Souza, PhD    +233244434966    ddesouza@noguchi.ug.edu.gh   
Contact: Susan Adu-Amamkwah, BPharm, MPH       sadu-amankwah@noguchi.ug.edu.gh   
Sponsors and Collaborators
Noguchi Memorial Institute for Medical Research
Ghana Health Services
Investigators
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Principal Investigator: Dziedzom K de Souza, PhD Noguchi Memorial Institute for Medical Research

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Noguchi Memorial Institute for Medical Research
ClinicalTrials.gov Identifier: NCT03036059     History of Changes
Other Study ID Numbers: TMA 2015 CDF - 976
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared publicly. Researchers interested in the data can contact the principal investigator directly. No personal identifying information will be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Noguchi Memorial Institute for Medical Research:
Twice a year treatment
Biannual treatment
Wuchereria bancrofti
Additional relevant MeSH terms:
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Ivermectin
Infection
Filariasis
Elephantiasis, Filarial
Helminthiasis
Elephantiasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Parasitic Diseases
Lymphedema
Lymphatic Diseases
Albendazole
Antiparasitic Agents
Anti-Infective Agents
Anthelmintics
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents