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

Study Overview
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Brief Summary
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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

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

Conditions
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Procalcitonin, Fever Without Source, Bacterial Infection, Bacteremia

Intervention / Treatment
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* Other: Procalcitonin dosage PCT-Q test (Brahms, Germany)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCT+<br>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 | Other: Procalcitonin dosage PCT-Q test (Brahms, Germany)<br>* Procalcitonin result available to the attending physician<br>* Other names: PCT-Q test (Brahms, Germany);|
| No Intervention: PCT-<br>Investigations include CBC, blood culture, urine analysis and culture and procalcitonin. In this arm, procalcitonin is not revealed to the attending physician. The decision to treat with antibiotics or to hospitalize was left to him. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in prescription of antibiotics between the two groups, excluding those treated for a bacterial infection identified by the ED investigations |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in hospitalization rate between the two groups (excluding those hospitalized for an identified infection) |  |  | 
| Procalcitonin sensitivity and specificity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Procalcitonin, Antibiotic, Fever without source, Fever without focus, bacteremia, Urinary tract infection