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

Not Applicable

Completed

• Conditions: Procalcitonin; Fever Without Source; Bacterial Infection; Bacteremia
• Interventions: Other: Procalcitonin dosage PCT-Q test (Brahms, Germany)

• Registration Number: NCT00692848
• Lead Sponsor: St. Justine's Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2007-11
• Status Verified: 2008-06
• Study Completion: 2008-06
• Study First Submitted: 2008-06-04
• Study First Submitted QC: 2008-06-05
• Last Update Submitted: 2008-06-05
• Study First Posted: 2008-06-06
• Last Update Posted: 2008-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 384

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCT+	Procalcitonin dosage PCT-Q test (Brahms, Germany)	Investigations include CBC, blood culture, urine analysis and culture and procalcitonin. In this arm procalcitonin result is revealed to the attending physician. The decision to treat with antibiotics or to hospitalize was left to him

Primary Outcome Measures

Name	Time	Method
Difference in prescription of antibiotics between the two groups, excluding those treated for a bacterial infection identified by the ED investigations

Secondary Outcome Measures

Name	Time	Method
Difference in hospitalization rate between the two groups (excluding those hospitalized for an identified infection)
Procalcitonin sensitivity and specificity

Trial Locations

Locations (1)

CHU Sainte-Justine Emergency Department; 🇨🇦 Montreal, Quebec, Canada