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

NCT02179398 | Completed Results

• 1 other identifier: 09-162 (MatPed 09-032)
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

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).

Conditions

Fever Without Source

Keywords

Fever without source; Antibiotic prescription; Serious bacterial infection

Outcome Measures

Primary Outcomes (1)

• Antibiotic Prescription Rate

  at PED (Pediatric Emergency Department) presentation

Secondary Outcomes (6)

• Presence of Serious Bacterial Infection

  at 72 hours from PED presentation

• Hospitalization Rate

  at PED presentation

• Sensitivity of a Lab-score ≥ 3

  at 72 hours from PED presentation

• Specificity of a Lab-score ≥ 3

  at 72 hours from PED presentation

• Sensitivity of Standard Biological Marker for SBI

  at 72 hours from PED presentation

Study Arms (2)

Lab-score group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Allocation to the Lab-score group BIOLOGICAL

Lab-score group

Allocation to the control group BIOLOGICAL

Control group

Eligibility Criteria

• Age: 7 Days - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children aged 7 days to 3 years old
• fever without source ≥ 100.4°F (≥ 38.0°C)

You may not qualify if:

• antibiotics received in the previous 48 hours
• underlying congenital or acquired immunodeficiency syndrome
• fever for more than 7 days at presentation

Sponsors & Collaborators

• University Hospital, Geneva: lead
• BioMérieux: collaborator

Study Sites (1)

Children's Hospital, Geneva University Hospital

Geneva, Geneva 14, 1211, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 18536624 BACKGROUND

• 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.

  PMID: 20515973 BACKGROUND

• 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.

  PMID: 22760529 BACKGROUND

• 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.

  PMID: 25503770 DERIVED

Limitations and Caveats

* heterogeneity in the total number of participating physicians (30) * recruitment in a tertiary care center (recruitment bias)

Results Point of Contact

• Title: Dr. Laurence Lacroix
• Organization: Geneva University Hospital

laurence.lacroix@hcuge.ch

+41223725082

Study Officials

• Laurence E Lacroix

  Children's Hospital, Geneva University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 27, 2014
• First Posted: July 1, 2014
• Study Start: September 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 31, 2014
• Results First Posted: October 31, 2014

Record last verified: 2014-10

Locations

CH (1)