Impact of the Lab-score on Antibiotic Prescription Rate in Children With Fever Without Source

Study Overview
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Brief Summary
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Detecting serious bacterial infections (SBI) in children presenting to the Pediatric Emergency Department (PED) with fever without source (FWS) is a frequent diagnostic challenge. The recently described Lab-score, based on the combined determination of Procalcitonin, C-Reactive Protein (CRP) and urine dipstick results, has been shown an accurate tool for SBI prediction on retrospective cohorts. The investigators aimed to assess the usefulness of the Lab-score in safely decreasing unnecessary antibiotic prescriptions in children with FWS, and to prospectively determine the diagnostic characteristics of the Lab-score compared to other classically used SBI biomarkers (white blood cell (WBC) count, band count and CRP).

Official Title
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Impact of the Lab-score on Antibiotic Prescription Rate in Children Aged 7 Days to 3 Years Old With Fever Without Source.

Conditions
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Fever Without Source

Intervention / Treatment
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* Biological: Allocation to the Lab-score group
* Biological: Allocation to the control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children aged 7 days to 3 years old fever without source ≥ 100.4°F (≥ 38.0°C) Exclusion Criteria: antibiotics received in the previous 48 hours underlying congenital or acquired immunodeficiency syndrome fever for more than 7 days at presentation

Ages Eligible for Study
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Minimum Age: 7 Days
Maximum Age: 3 Years

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lab-score group<br>Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection. (WBC and band counts blinded to the physician in charge of the patient) | Biological: Allocation to the Lab-score group<br> <br> |
| Active Comparator: Control group<br>Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: WBC count, band count and CRP determination. (PCT and thus Lab-score blinded to the physician in charge of the patient). | Biological: Allocation to the control group<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotic Prescription Rate |  | at PED (Pediatric Emergency Department) presentation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Serious Bacterial Infection |  | at 72 hours from PED presentation | 
| Hospitalization Rate |  | at PED presentation | 
| Sensitivity of a Lab-score ≥ 3 |  | at 72 hours from PED presentation | 
| Specificity of a Lab-score ≥ 3 |  | at 72 hours from PED presentation | 
| Sensitivity of Standard Biological Marker for SBI | Sensitivity of standard biological marker for SBI: WBC ≥ 15'000/mm³ and/or bands ≥ 1'500/mm³ and/or CRP ≥ 40 mg/L | at 72 hours from PED presentation | 
| Specificity of Standard Biological Marker for SBI | Specificity of standard biological marker for SBI: WBC ≥ 15'000/mm³ and/or bands ≥ 1'500/mm³ and/or CRP ≥ 40 mg/L | at 72 hours from PED presentation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fever without source, Antibiotic prescription, Serious bacterial infection