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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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24 October 2016 |
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Main ID: |
NCT02225769 |
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Date of registration:
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22/08/2014 |
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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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Electronic Algorithms Based on Host Biomarkers to Manage Febrile Children
e-POCT |
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Scientific title:
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Electronic Algorithms Based on Host Biomarkers Point of Care Tests to Decide on Admission and Antibiotic Prescription in Tanzanian Febrile Children |
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Date of first enrolment:
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December 2014 |
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Target sample size:
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3192 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02225769 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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Tanzania
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Contacts
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Name:
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Valérie D'Acremont, MD, PhD, MiH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Swiss Tropical & Public Health Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age =2 months and <60 months of age
- Written informed consent from the child's parent or caregiver
- Axillary temperature =37.5°C and/or tympanic temperature =38.0°C
- History of fever for =7 days
- First consultation for the current illness
- Live in the catchment area of the health facility
Exclusion Criteria:
- Age 60 months or greater
- Age less than 2 months
- Weight less than 2.5kg
- Chief health problem is an injury, trauma or acute poisoning
Age minimum:
2 Months
Age maximum:
59 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Febrile Illness
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Intervention(s)
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Other: Management of febrile children using ALMANACH
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Other: Management of febrile children using e-POCT
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Primary Outcome(s)
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Proportion of clinical failure by day 7 compared among the 3 study arms.
[Time Frame: 10 months]
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Secondary Outcome(s)
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Proportions of children prescribed an antibiotic and/or antimalarial treatment at day 0 and by day 7 compared among the 3 study arms.
[Time Frame: 10 months]
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Proportion of primarily admitted children compared among the 3 study arms.
[Time Frame: 10 months]
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Proportions of secondary hospitalization and death by day 30 compared among the 3 study arms.
[Time Frame: 10 months]
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Proportions of children with hypoxemia, stratified by diagnostic classification (e-POCT arm)
[Time Frame: 10 months]
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Secondary ID(s)
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IZ01Z0_146896
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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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