N/A
N=278
Impact of the Lab-score on Antibiotic Prescription Rate in Children With Fever Without Source
Fever Without Source
Bottom Line
View on ClinicalTrials.gov: NCT02179398 ↗Enrolled (actual)
278
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Antibiotic Prescription Rate — 54; 59 participants — p=1
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Allocation to the Lab-score group (Biological); Allocation to the control group (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University Hospital, Geneva
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Antibiotic Prescription Rate |
54; 59 | 1 |
| SECONDARY Presence of Serious Bacterial Infection |
32; 35 | 1 |
| SECONDARY Hospitalization Rate |
44; 50 | 0.810 |
| SECONDARY Sensitivity of a Lab-score ≥ 3 |
85.1; 80.0 | — |
| SECONDARY Specificity of a Lab-score ≥ 3 |
87.3; 93.1 | — |
| SECONDARY Sensitivity of Standard Biological Marker for SBI |
83.6; 70.0 | — |
| SECONDARY Specificity of Standard Biological Marker for SBI |
68.8; 79.3 | — |
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
Data sourced from ClinicalTrials.gov (NCT02179398). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.