Clinical trial NCT02179398: 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
Overall status: COMPLETED
Phase: NA
Conditions: Fever Without Source
Keywords: Fever without source
Antibiotic prescription
Serious bacterial infection
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: BioMérieux
First posted: 2014-07-01
Enrollment: 278
Sex: ALL
Minimum age (years): 7
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).


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

Primary outcomes:
measure: Antibiotic Prescription Rate
timeFrame: at PED (Pediatric Emergency Department) presentation
Secondary outcomes:
measure: Presence of Serious Bacterial Infection
timeFrame: at 72 hours from PED presentation
measure: Hospitalization Rate
timeFrame: at PED presentation
measure: Sensitivity of a Lab-score ≥ 3
timeFrame: at 72 hours from PED presentation
measure: Specificity of a Lab-score ≥ 3
timeFrame: at 72 hours from PED presentation
measure: Sensitivity of Standard Biological Marker for SBI
timeFrame: at 72 hours from PED presentation
measure: Specificity of Standard Biological Marker for SBI
timeFrame: at 72 hours from PED presentation
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Children's Hospital, Geneva University Hospital
state: Geneva 14
Study officials:
affiliation: Children's Hospital, Geneva University Hospital
name: Laurence E Lacroix
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.