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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03036059 |
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Date of registration:
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03/11/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Twice Yearly Treatment for the Control of LF
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Scientific title:
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Cluster Randomized Community-based Trial of Annual Versus Biannual Single-dose Ivermectin Plus Albendazole Against Wuchereria Bancrofti Infection in Human and Mosquito Populations |
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Date of first enrolment:
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May 19, 2017 |
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Target sample size:
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1462 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03036059 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Ghana
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Contacts
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Name:
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Dziedzom K de Souza, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Noguchi Memorial Institute for Medical Research |
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Key inclusion & exclusion criteria
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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.
Age minimum:
5 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lymphatic Filariasis
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Helminth Infection
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Intervention(s)
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Drug: 400 µg/kg Ivermectin + 400 mg Albendazole
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Primary Outcome(s)
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Change from baseline prevalence of Lymphatic Filariasis at 24 months
[Time Frame: 0 and 24 months]
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Secondary Outcome(s)
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Evaluation of community acceptability of twice-yearly treatment, through questionnaires and focus group discussions
[Time Frame: 24 months]
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Longitudinal assessment of transmission dynamics of Lymphatic Filariasis for modelling the impact of treatment
[Time Frame: 0, 12, 24, 30 months]
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Feasibility of scale-up of twice-yearly treatment, through questionnaires and focus group discussions
[Time Frame: 24 months]
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Secondary ID(s)
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TMA 2015 CDF - 976
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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