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

Fever Without Source Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02179398
• Other study ID #: 09-162 (MatPed 09-032)
• Status: Completed
• Phase: N/A
• First received: June 27, 2014
• Last updated: October 26, 2014
• Start date: September 2010
• Est. completion date: July 2013

Study information

• Verified date: October 2014
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fever
• Fever Without Source

Intervention

Biological:
• Allocation to the Lab-score group

• Allocation to the control group

Locations

Country	Name	City	State
Switzerland	Children's Hospital, Geneva University Hospital	Geneva	Geneva 14

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Geneva	BioMérieux

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibiotic Prescription Rate		at PED (Pediatric Emergency Department) presentation	No
Secondary	Presence of Serious Bacterial Infection		at 72 hours from PED presentation	No
Secondary	Hospitalization Rate		at PED presentation	No
Secondary	Sensitivity of a Lab-score = 3		at 72 hours from PED presentation	No
Secondary	Specificity of a Lab-score = 3		at 72 hours from PED presentation	No
Secondary	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	at 72 hours from PED presentation	No
Secondary	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	at 72 hours from PED presentation	No