Bacteremia Clinical Trial
Official title:
The Impact of Procalcitonin on the Management of Children Aged 1 to 36 Month Presenting With a Fever Without a Source
Verified date | June 2008 |
Source | St. Justine's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
Serious bacterial infections are often difficult to detect in children with fever without source. Procalcitonin is a better blood marker of infection than White blood cell count and possibly than C-reactive protein. This could lead to a reduction in antibiotic prescription. Our objective is to evaluate the impact of Procalcitonin result on antibiotic prescription in children 1 to 36 month old with fever without source and our hypothesis is that it will lower the antibiotic prescription rate
Status | Completed |
Enrollment | 384 |
Est. completion date | June 2008 |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Month to 36 Months |
Eligibility |
Inclusion Criteria: - Children 1-36 months - With rectal temperature >38.0 C - And no identified source of infection after history and physical examination Exclusion Criteria: - acquired or congenital immunodeficiency |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Canada | CHU Sainte-Justine Emergency Department | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
St. Justine's Hospital |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in prescription of antibiotics between the two groups, excluding those treated for a bacterial infection identified by the ED investigations | No | ||
Secondary | Difference in hospitalization rate between the two groups (excluding those hospitalized for an identified infection) | No | ||
Secondary | Procalcitonin sensitivity and specificity | No |
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