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

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ClinicalTrials.gov Identifier: NCT02179398
Recruitment Status : Completed
First Posted : July 1, 2014
Results First Posted : October 31, 2014
Last Update Posted : October 31, 2014
Sponsor:
Collaborator:
BioMérieux
Information provided by (Responsible Party):
Laurence Lacroix, 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).

Condition or disease Intervention/treatment Phase
Fever Without Source Biological: Allocation to the Lab-score group Biological: Allocation to the control group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : September 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Fever

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



Primary Outcome Measures :
  1. Antibiotic Prescription Rate [ Time Frame: at PED (Pediatric Emergency Department) presentation ]

Secondary Outcome Measures :
  1. Presence of Serious Bacterial Infection [ Time Frame: at 72 hours from PED presentation ]
  2. Hospitalization Rate [ Time Frame: at PED presentation ]
  3. Sensitivity of a Lab-score ≥ 3 [ Time Frame: at 72 hours from PED presentation ]
  4. Specificity of a Lab-score ≥ 3 [ Time Frame: at 72 hours from PED presentation ]
  5. 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

  6. 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



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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02179398


Locations
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Switzerland
Children's Hospital, Geneva University Hospital
Geneva, Geneva 14, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
BioMérieux
Investigators
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Principal Investigator: Laurence E Lacroix Children's Hospital, Geneva University Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Laurence Lacroix, Dr, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02179398     History of Changes
Other Study ID Numbers: 09-162 (MatPed 09-032)
First Posted: July 1, 2014    Key Record Dates
Results First Posted: October 31, 2014
Last Update Posted: October 31, 2014
Last Verified: October 2014

Keywords provided by Laurence Lacroix, University Hospital, Geneva:
Fever without source
Antibiotic prescription
Serious bacterial infection

Additional relevant MeSH terms:
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Fever
Body Temperature Changes
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents