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

Not Applicable

Completed

• Conditions: Fever Without Source
• Interventions: Biological: Allocation to the Lab-score group; Biological: Allocation to the control group

• Registration Number: NCT02179398
• Lead Sponsor: University Hospital, Geneva

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Study First Submitted: 2014-06-27
• Study First Submitted QC: 2014-06-30
• Study First Posted: 2014-07-01
• Status Verified: 2014-10
• Results First Submitted: 2014-10-21
• Results First Submitted QC: 2014-10-26
• Last Update Submitted: 2014-10-26
• Results First Posted: 2014-10-31
• Last Update Posted: 2014-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lab-score group	Allocation to the Lab-score group	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)
Control group	Allocation to the control group	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).

Primary Outcome Measures

Name	Time	Method
Antibiotic Prescription Rate	at PED (Pediatric Emergency Department) presentation

Secondary Outcome Measures

Name	Time	Method
Specificity of a Lab-score ≥ 3	at 72 hours from PED presentation
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
Sensitivity of Standard Biological Marker for SBI	at 72 hours from PED presentation	Sensitivity of standard biological marker for SBI: WBC ≥ 15'000/mm³ and/or bands ≥ 1'500/mm³ and/or CRP ≥ 40 mg/L
Specificity of Standard Biological Marker for SBI	at 72 hours from PED presentation	Specificity of standard biological marker for SBI: WBC ≥ 15'000/mm³ and/or bands ≥ 1'500/mm³ and/or CRP ≥ 40 mg/L

Trial Locations

Locations (1)

Children's Hospital, Geneva University Hospital; 🇨🇭 Geneva, Geneva 14, Switzerland