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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: |
NCT02926625 |
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Date of registration:
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03/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Universal Versus Conditional Three-day Follow-up Visit for Children With Unclassified Fever
TRAction |
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Scientific title:
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Universal Versus Conditional Three-day Follow-up Visit for Children With Unclassified Fever at the Community Level: A Study to be Conducted in Ethiopia |
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Date of first enrolment:
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December 1, 2015 |
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Target sample size:
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4179 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02926625 |
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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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Ethiopia
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Contacts
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Name:
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Karin Kallander, MSc, 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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Malaria Consortium |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Non-severe febrile illness that is classified by HEW as unspecific fever
Exclusion Criteria:
- Malaria, pneumonia, diarrhoea diagnosis
- Symptoms requiring referral
Age minimum:
2 Months
Age maximum:
59 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Fever
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Intervention(s)
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Behavioral: Systematic follow-up
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Behavioral: Conditional follow-up
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Primary Outcome(s)
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Treatment failure
[Time Frame: Day 7]
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Secondary Outcome(s)
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Proportion of caregivers who spontaneously re-present to HEWs
[Time Frame: Day 0-7]
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Illness classification among children with unresolved illness
[Time Frame: Day 7]
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Secondary treatment
[Time Frame: Day 0-7]
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Hospital admission rate
[Time Frame: Day 0-7]
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Proportion of caregivers who present to HEWs for the follow-up visit on Day 3
[Time Frame: Day 3]
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Secondary ID(s)
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FY15-G04-6990
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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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