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

University Hospitals (UH)

Status: Completed

Conditions: Fever Without Source

Treatments: Biological: Allocation to the control group; Biological: Allocation to the Lab-score group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02179398

09-162 (MatPed 09-032)

Details and patient eligibility

About

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).

Enrollment: 278 patients

Sex: All

Ages: 7 days to 3 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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278 participants in 2 patient groups

Lab-score group

Experimental group

Description:

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)

Treatment:

Biological: Allocation to the Lab-score group

Control group

Active Comparator group

Description:

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).

Treatment:

Biological: Allocation to the control group