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

Not Applicable

Completed

• Conditions: Fever Without Source

• 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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Specificity of a Lab-score ≥ 3	at 72 hours from PED presentation
Presence of Serious Bacterial Infection	at 72 hours from PED presentation

Trial Locations

Locations (1)

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