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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02179398

Enrollment

278

Registered

2014-07-01

Start date

2010-09-30

Completion date

2013-07-31

Last updated

2014-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever Without Source

Keywords

Fever without source, Antibiotic prescription, Serious bacterial infection

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).

Interventions

BIOLOGICALAllocation to the Lab-score group

BIOLOGICALAllocation to the control group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

7 Days to 3 Years

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

Design outcomes

Primary

Measure	Time frame
Antibiotic Prescription Rate	at PED (Pediatric Emergency Department) presentation

Secondary

Measure	Time frame	Description
Presence of Serious Bacterial Infection	at 72 hours from PED presentation	—
Hospitalization Rate	at PED presentation	—
Specificity of Standard Biological Marker for SBI	at 72 hours from PED presentation	Specificity of standard biological marker for SBI: WBC ≥ 15'000/mm³ and/or bands ≥ 1'500/mm³ and/or CRP ≥ 40 mg/L
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	Sensitivity of standard biological marker for SBI: WBC ≥ 15'000/mm³ and/or bands ≥ 1'500/mm³ and/or CRP ≥ 40 mg/L
Sensitivity of a Lab-score ≥ 3	at 72 hours from PED presentation	—

Countries

Switzerland

Participant flow

Participants by arm

Arm	Count
Lab-score Group 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) Allocation to the Lab-score group	131
Control Group 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). Allocation to the control group	140
Total	271

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lack of obligatory data	3	3
Overall Study	Lost to Follow-up	0	1

Baseline characteristics

Characteristic	Lab-score Group	Control Group	Total
Age, Continuous	4.8 months	3.4 months	4.0 months
Fever duration 12-24 hours	25 participants	24 participants	49 participants
Fever duration < 12 hours	47 participants	55 participants	102 participants
Fever duration > 24 hours	59 participants	61 participants	120 participants
Lab-score value	2.03 units on a scale STANDARD_DEVIATION 2.62	2.04 units on a scale STANDARD_DEVIATION 2.86	2.04 units on a scale STANDARD_DEVIATION 2.74
Maximum temperature	39.3 °C STANDARD_DEVIATION 0.8	39.3 °C STANDARD_DEVIATION 0.8	39.3 °C STANDARD_DEVIATION 0.78
Presence of Serious Bacterial Infection (SBI)	32 participants	35 participants	67 participants
Sex: Female, Male Female	66 Participants	69 Participants	135 Participants
Sex: Female, Male Male	65 Participants	71 Participants	136 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 131	0 / 140
serious Total, serious adverse events	0 / 131	0 / 140

Outcome results

Primary

Antibiotic Prescription Rate

Time frame: at PED (Pediatric Emergency Department) presentation

Population: children 7 days - 36 months old presenting to the PED with fever without source (FWS) ≥38.0°C (≥ 100.4°F) after a thorough history and careful examination

Arm	Measure	Value (NUMBER)
Lab-score Group	Antibiotic Prescription Rate	54 participants
Control Group	Antibiotic Prescription Rate	59 participants

p-value: 1Chi-squared

Secondary

Hospitalization Rate

Time frame: at PED presentation

Arm	Measure	Value (NUMBER)
Lab-score Group	Hospitalization Rate	44 participants
Control Group	Hospitalization Rate	50 participants

Comparison: Power calculation suggested 97 patients should be enrolled in each group to give 80% power at the 5% level of significance to detect a 20% difference in antibiotic prescription ratep-value: 0.81Chi-squared

Secondary