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

NCT ID: NCT02179398

Last Updated: 2014-10-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-07-31

Brief Summary

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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

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Conditions

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Fever Without Source

Keywords

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Fever without source Antibiotic prescription Serious bacterial infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Allocation to the Lab-score group

Intervention Type BIOLOGICAL

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).

Group Type ACTIVE_COMPARATOR

Allocation to the control group

Intervention Type BIOLOGICAL

Interventions

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Allocation to the Lab-score group

Intervention Type BIOLOGICAL

Allocation to the control group

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

7 Days

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioMérieux

INDUSTRY

Sponsor Role collaborator

University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Laurence Lacroix

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laurence E Lacroix

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital, Geneva University Hospital

Locations

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Children's Hospital, Geneva University Hospital

Geneva, Geneva 14, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 18536624 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20515973 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22760529 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25503770 (View on PubMed)

Other Identifiers

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09-162 (MatPed 09-032)

Identifier Type: -

Identifier Source: org_study_id