Impact of the Lab-score on Antibiotic Prescription Rate in Children With Fever Without Source
Primary Purpose
Fever Without Source
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Allocation to the Lab-score group
Allocation to the control group
Sponsored by
About this trial
This is an interventional diagnostic trial for Fever Without Source focused on measuring Fever without source, Antibiotic prescription, Serious bacterial infection
Eligibility Criteria
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
Sites / Locations
- Children's Hospital, Geneva University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lab-score group
Control group
Arm Description
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)
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).
Outcomes
Primary Outcome Measures
Antibiotic Prescription Rate
Secondary Outcome Measures
Presence of Serious Bacterial Infection
Hospitalization Rate
Sensitivity of a Lab-score ≥ 3
Specificity of a Lab-score ≥ 3
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
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
Full Information
NCT ID
NCT02179398
First Posted
June 27, 2014
Last Updated
October 26, 2014
Sponsor
University Hospital, Geneva
Collaborators
BioMérieux
1. Study Identification
Unique Protocol Identification Number
NCT02179398
Brief Title
Impact of the Lab-score on Antibiotic Prescription Rate in Children With Fever Without Source
Official Title
Impact of the Lab-score on Antibiotic Prescription Rate in Children Aged 7 Days to 3 Years Old With Fever Without Source.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
Collaborators
BioMérieux
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever Without Source
Keywords
Fever without source, Antibiotic prescription, Serious bacterial infection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
278 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lab-score group
Arm Type
Experimental
Arm Description
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)
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
Allocation to the Lab-score group
Intervention Type
Biological
Intervention Name(s)
Allocation to the control group
Primary Outcome Measure Information:
Title
Antibiotic Prescription Rate
Time Frame
at PED (Pediatric Emergency Department) presentation
Secondary Outcome Measure Information:
Title
Presence of Serious Bacterial Infection
Time Frame
at 72 hours from PED presentation
Title
Hospitalization Rate
Time Frame
at PED presentation
Title
Sensitivity of a Lab-score ≥ 3
Time Frame
at 72 hours from PED presentation
Title
Specificity of a Lab-score ≥ 3
Time Frame
at 72 hours from PED presentation
Title
Sensitivity of Standard Biological Marker for SBI
Description
Sensitivity of standard biological marker for SBI: WBC ≥ 15'000/mm³ and/or bands ≥ 1'500/mm³ and/or CRP ≥ 40 mg/L
Time Frame
at 72 hours from PED presentation
Title
Specificity of Standard Biological Marker for SBI
Description
Specificity of standard biological marker for SBI: WBC ≥ 15'000/mm³ and/or bands ≥ 1'500/mm³ and/or CRP ≥ 40 mg/L
Time Frame
at 72 hours from PED presentation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence E Lacroix
Organizational Affiliation
Children's Hospital, Geneva University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital, Geneva University Hospital
City
Geneva
State/Province
Geneva 14
ZIP/Postal Code
1211
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
18536624
Citation
Lacour AG, Zamora SA, Gervaix A. A score identifying serious bacterial infections in children with fever without source. Pediatr Infect Dis J. 2008 Jul;27(7):654-6. doi: 10.1097/INF.0b013e318168d2b4.
Results Reference
background
PubMed Identifier
20515973
Citation
Galetto-Lacour A, Zamora SA, Andreola B, Bressan S, Lacroix L, Da Dalt L, Gervaix A. Validation of a laboratory risk index score for the identification of severe bacterial infection in children with fever without source. Arch Dis Child. 2010 Dec;95(12):968-73. doi: 10.1136/adc.2009.176800. Epub 2010 Jun 1.
Results Reference
background
PubMed Identifier
22760529
Citation
Bressan S, Gomez B, Mintegi S, Da Dalt L, Blazquez D, Olaciregui I, de la Torre M, Palacios M, Berlese P, Ruano A. Diagnostic performance of the lab-score in predicting severe and invasive bacterial infections in well-appearing young febrile infants. Pediatr Infect Dis J. 2012 Dec;31(12):1239-44. doi: 10.1097/INF.0b013e318266a9aa.
Results Reference
background
PubMed Identifier
25503770
Citation
Lacroix L, Manzano S, Vandertuin L, Hugon F, Galetto-Lacour A, Gervaix A. Impact of the lab-score on antibiotic prescription rate in children with fever without source: a randomized controlled trial. PLoS One. 2014 Dec 11;9(12):e115061. doi: 10.1371/journal.pone.0115061. eCollection 2014.
Results Reference
derived
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Impact of the Lab-score on Antibiotic Prescription Rate in Children With Fever Without Source
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