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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: |
NCT03177993 |
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Date of registration:
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31/05/2017 |
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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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Fiji Integrated Therapy (FIT) - Triple Therapy for Lymphatic Filariasis, Scabies and Soil Transmitted Helminths in Fiji
FIT |
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Scientific title:
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Community Based Safety Study of 2-drug (Diethylcarbamazine and Albendazole) Versus 3-drug (Ivermectin, Diethylcarbamazine and Albendazole) Therapy for Lymphatic Filariasis, Scabies and Soil Transmitted Helminths in Fiji |
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Date of first enrolment:
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July 13, 2017 |
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Target sample size:
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4773 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03177993 |
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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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N/A
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Countries of recruitment
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Fiji
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Contacts
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Name:
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Christopher King, MD 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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Case Western Reserve University |
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Name:
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Andrew Steer, 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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Murdoch Children's Research Institute |
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Name:
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Gary Weil, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Washington University School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All community members that have given written informed consent to participate
Exclusion Criteria:
- No informed consent
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Soil Transmitted Helminths
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Lymphatic Filariases
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Scabies
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Impetigo
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Intervention(s)
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Drug: 2 drug dose - DA
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Drug: 3 drug dose - IDA with second dose of ivermectin
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Drug: 3 drug dose - IDA
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Primary Outcome(s)
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Frequency, type, and severity of adverse events reported by participants following treatment with triple drug therapy (IDA) and standard two drug therapy (DA) in LF infected and uninfected individuals in a community as measured by CTCAE v4.03
[Time Frame: within 7 days of drug administration]
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Secondary Outcome(s)
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Prevalence of scabies in study population measured at baseline and 12 months after treatment using the WHO Integrated Management of Childhood Illness (IMCI) skin algorithm
[Time Frame: Baseline and 12 months]
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Clearance of microfilariae (mf) and filarial antigenemia following treatment with IDA or DA in LF infected individuals as measured by microfilaria count in 60ul thick blood smears and filarial test strip rapid diagnostic antigen test.
[Time Frame: Baseline and 12 months]
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Acceptability and feasibility of IDA and DA in communities at risk of LF, scabies and STH as assessed by survey and focus group discussions.
[Time Frame: Approximately 4 weeks following treatment]
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Prevalence of impetigo measured at baseline and 12 months after treatment using the WHO Integrated Management of Childhood Illness (IMCI) skin algorithm
[Time Frame: Baseline and 12 months]
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Prevalence of STH (hookworm, ascaris, trichuris and strongyloides) as measured by Kato-katz or PCR at baseline and 12 months after treatment
[Time Frame: Stool collected at baseline (pre-treatment), 4 weeks (individual response), and 12 months (community prevalence).]
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Secondary ID(s)
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201607068-2
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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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