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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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ISRCTN |
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Last refreshed on:
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25 July 2023 |
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Main ID: |
ISRCTN13858170 |
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Date of registration:
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10/06/2015 |
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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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Feasibility, acceptability and costs of diagnosis and management of malaria in the community
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Scientific title:
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Feasibility, acceptability and costs of diagnosis and management of uncomplicated and severe malaria in the community |
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Date of first enrolment:
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01/09/2015 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN13858170 |
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Study type:
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Observational |
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Study design:
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Observational study of community based diagnosis and management of malaria. (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Burkina Faso
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Nigeria
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Uganda
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Melba
Gomes |
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Address:
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World Health Organization
1211
Geneva
Switzerland |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Febrile children aged 6 months to 59 months
Exclusion criteria: Age below 6 months or above 59 months
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Uncomplicated and severe malaria
Infections and Infestations
Protozoal diseases
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Intervention(s)
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For the 12 month intervention period:
1. Diagnosis at point of care with a rapid diagnostic test (RDT)
2. Treatment of uncomplicated RDT positive cases with artemeter-lumefantrine (artemisinin combination treatment) and treatment of severe cases with rectal artesunate
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Primary Outcome(s)
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Feasibility, acceptability, costs of a diagnosis and treatment package in the community. Severe malaria cases are followed up (to monitor compliance with referral advice, and vital status/wellbeing at follow up), and uncomplicated cases are monitored for diagnosis and treatment.
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Secondary Outcome(s)
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Treatment seeking behaviour and promptness of access to diagnosis and care.
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Secondary ID(s)
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A80550 A80553 A80556
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Source(s) of Monetary Support
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European Commission Directorate-General for Research and Innovation
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Ethics review
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Status:
Approval date:
Contact:
Old ethics approval format; World Health Organization Ethics Review Committee, 10/12/2009, refs: A80550-Nigeria, A80553-Burkina, A80556-Uganda.
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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30/09/2015 |
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URL:
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