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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00692848
Other study ID # URG73
Secondary ID
Status Completed
Phase N/A
First received June 4, 2008
Last updated June 5, 2008
Start date November 2006
Est. completion date June 2008

Study information

Verified date June 2008
Source St. Justine's Hospital
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic


Intervention

Other:
Procalcitonin dosage PCT-Q test (Brahms, Germany)
Procalcitonin result available to the attending physician

Locations

Country Name City State
Canada CHU Sainte-Justine Emergency Department Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

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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