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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00692848
Enrollment
384
Registered
2008-06-06
Start date
2006-11-30
Completion date
2008-06-30
Last updated
2008-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacteremia, Bacterial Infection, Fever Without Source, Procalcitonin

Keywords

Procalcitonin, Antibiotic, Fever without source, Fever without focus, bacteremia, Urinary tract infection

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

Interventions

OTHERProcalcitonin dosage PCT-Q test (Brahms, Germany)

Procalcitonin result available to the attending physician

Sponsors

St. Justine's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Months to 36 Months
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026