Impact of Procalcitonin on the Management of Children Aged 1 to 36 Month Presenting With a Fever Without a Source

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00692848
• Other study ID #: URG73
• 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

Related Conditions & MeSH terms

• Bacteremia
• Bacterial Infection
• Bacterial Infections
• Fever
• Fever Without Source
• Procalcitonin

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