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

October 26, 2014 updated by: Laurence Lacroix, University Hospital, Geneva

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

278

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Geneva 14
      • Geneva, Geneva 14, Switzerland, 1211
        • Children's Hospital, Geneva University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Biological: Allocation to the Lab-score group
Active Comparator: 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).
Biological: Allocation to the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Antibiotic Prescription Rate
Time Frame: at PED (Pediatric Emergency Department) presentation
at PED (Pediatric Emergency Department) presentation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of Serious Bacterial Infection
Time Frame: at 72 hours from PED presentation
at 72 hours from PED presentation
Hospitalization Rate
Time Frame: at PED presentation
at PED presentation
Sensitivity of a Lab-score ≥ 3
Time Frame: at 72 hours from PED presentation
at 72 hours from PED presentation
Specificity of a Lab-score ≥ 3
Time Frame: at 72 hours from PED presentation
at 72 hours from PED presentation
Sensitivity of Standard Biological Marker for SBI
Time Frame: 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
at 72 hours from PED presentation
Specificity of Standard Biological Marker for SBI
Time Frame: 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
at 72 hours from PED presentation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Collaborators

BioMérieux

Investigators

  • Principal Investigator: Laurence E Lacroix, Children's Hospital, Geneva University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

June 27, 2014

First Submitted That Met QC Criteria

June 30, 2014

First Posted (Estimate)

July 1, 2014

Study Record Updates

Last Update Posted (Estimate)

October 31, 2014

Last Update Submitted That Met QC Criteria

October 26, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-162 (MatPed 09-032)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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