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

NCT02179398 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2014-10-31

Study results available
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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).

Conditions

  • Fever Without Source

Interventions

BIOLOGICAL

Allocation to the Lab-score group

BIOLOGICAL

Allocation to the control group

Sponsors & Collaborators

  • BioMérieux

    collaborator INDUSTRY
  • University Hospital, Geneva

    lead OTHER

Principal Investigators

  • Laurence E Lacroix · Children's Hospital, Geneva University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Days
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02179398 on ClinicalTrials.gov