Trial Outcomes & Findings for Impact of the Lab-score on Antibiotic Prescription Rate in Children With Fever Without Source (NCT NCT02179398)
NCT ID: NCT02179398
Last Updated: 2014-10-31
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
278 participants
Primary outcome timeframe
at PED (Pediatric Emergency Department) presentation
Results posted on
2014-10-31
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
134
|
144
|
|
Overall Study
COMPLETED
|
131
|
140
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Lack of obligatory data
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Impact of the Lab-score on Antibiotic Prescription Rate in Children With Fever Without Source
Baseline characteristics by cohort
| Measure |
Lab-score Group
n=131 Participants
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
|
Control Group
n=140 Participants
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
|
Total
n=271 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4.8 months
n=93 Participants
|
3.4 months
n=4 Participants
|
4.0 months
n=27 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=93 Participants
|
69 Participants
n=4 Participants
|
135 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=93 Participants
|
71 Participants
n=4 Participants
|
136 Participants
n=27 Participants
|
|
Fever duration
< 12 hours
|
47 participants
n=93 Participants
|
55 participants
n=4 Participants
|
102 participants
n=27 Participants
|
|
Fever duration
12-24 hours
|
25 participants
n=93 Participants
|
24 participants
n=4 Participants
|
49 participants
n=27 Participants
|
|
Fever duration
> 24 hours
|
59 participants
n=93 Participants
|
61 participants
n=4 Participants
|
120 participants
n=27 Participants
|
|
Maximum temperature
|
39.3 °C
STANDARD_DEVIATION 0.8 • n=93 Participants
|
39.3 °C
STANDARD_DEVIATION 0.8 • n=4 Participants
|
39.3 °C
STANDARD_DEVIATION 0.78 • n=27 Participants
|
|
Lab-score value
|
2.03 units on a scale
STANDARD_DEVIATION 2.62 • n=93 Participants
|
2.04 units on a scale
STANDARD_DEVIATION 2.86 • n=4 Participants
|
2.04 units on a scale
STANDARD_DEVIATION 2.74 • n=27 Participants
|
|
Presence of Serious Bacterial Infection (SBI)
|
32 participants
n=93 Participants
|
35 participants
n=4 Participants
|
67 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: at PED (Pediatric Emergency Department) presentationPopulation: 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
Outcome measures
| Measure |
Lab-score Group
n=131 Participants
Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.
(white blood cell (WBC) and band counts blinded to the physician in charge of the patient)
Allocation to the Lab-score group
|
Control Group
n=140 Participants
Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: white blood cell (WBC) count, band count and C-Reactive Protein (CRP) determination.
(Procalcitonin (PCT) and thus Lab-score blinded to the physician in charge of the patient).
Allocation to the control group
|
|---|---|---|
|
Antibiotic Prescription Rate
|
54 participants
|
59 participants
|
SECONDARY outcome
Timeframe: at 72 hours from PED presentationOutcome measures
| Measure |
Lab-score Group
n=131 Participants
Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.
(white blood cell (WBC) and band counts blinded to the physician in charge of the patient)
Allocation to the Lab-score group
|
Control Group
n=140 Participants
Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: white blood cell (WBC) count, band count and C-Reactive Protein (CRP) determination.
(Procalcitonin (PCT) and thus Lab-score blinded to the physician in charge of the patient).
Allocation to the control group
|
|---|---|---|
|
Presence of Serious Bacterial Infection
|
32 participants
|
35 participants
|
SECONDARY outcome
Timeframe: at PED presentationOutcome measures
| Measure |
Lab-score Group
n=131 Participants
Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.
(white blood cell (WBC) and band counts blinded to the physician in charge of the patient)
Allocation to the Lab-score group
|
Control Group
n=140 Participants
Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: white blood cell (WBC) count, band count and C-Reactive Protein (CRP) determination.
(Procalcitonin (PCT) and thus Lab-score blinded to the physician in charge of the patient).
Allocation to the control group
|
|---|---|---|
|
Hospitalization Rate
|
44 participants
|
50 participants
|
SECONDARY outcome
Timeframe: at 72 hours from PED presentationOutcome measures
| Measure |
Lab-score Group
n=271 Participants
Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.
(white blood cell (WBC) and band counts blinded to the physician in charge of the patient)
Allocation to the Lab-score group
|
Control Group
n=117 Participants
Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: white blood cell (WBC) count, band count and C-Reactive Protein (CRP) determination.
(Procalcitonin (PCT) and thus Lab-score blinded to the physician in charge of the patient).
Allocation to the control group
|
|---|---|---|
|
Sensitivity of a Lab-score ≥ 3
|
85.1 percentage of patients (sensitivity)
Interval 76.5 to 93.6
|
80.0 percentage of patients (sensitivity)
Interval 65.7 to 94.3
|
SECONDARY outcome
Timeframe: at 72 hours from PED presentationOutcome measures
| Measure |
Lab-score Group
n=271 Participants
Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.
(white blood cell (WBC) and band counts blinded to the physician in charge of the patient)
Allocation to the Lab-score group
|
Control Group
n=117 Participants
Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: white blood cell (WBC) count, band count and C-Reactive Protein (CRP) determination.
(Procalcitonin (PCT) and thus Lab-score blinded to the physician in charge of the patient).
Allocation to the control group
|
|---|---|---|
|
Specificity of a Lab-score ≥ 3
|
87.3 percentage of patients (specificity)
Interval 82.7 to 91.8
|
93.1 percentage of patients (specificity)
Interval 87.8 to 98.4
|
SECONDARY outcome
Timeframe: at 72 hours from PED presentationSensitivity of standard biological marker for SBI: WBC ≥ 15'000/mm³ and/or bands ≥ 1'500/mm³ and/or CRP ≥ 40 mg/L
Outcome measures
| Measure |
Lab-score Group
n=271 Participants
Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.
(white blood cell (WBC) and band counts blinded to the physician in charge of the patient)
Allocation to the Lab-score group
|
Control Group
n=117 Participants
Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: white blood cell (WBC) count, band count and C-Reactive Protein (CRP) determination.
(Procalcitonin (PCT) and thus Lab-score blinded to the physician in charge of the patient).
Allocation to the control group
|
|---|---|---|
|
Sensitivity of Standard Biological Marker for SBI
|
83.6 percentage of patients (sensitivity)
Interval 74.7 to 92.5
|
70.0 percentage of patients (sensitivity)
Interval 53.6 to 86.4
|
SECONDARY outcome
Timeframe: at 72 hours from PED presentationSpecificity of standard biological marker for SBI: WBC ≥ 15'000/mm³ and/or bands ≥ 1'500/mm³ and/or CRP ≥ 40 mg/L
Outcome measures
| Measure |
Lab-score Group
n=271 Participants
Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.
(white blood cell (WBC) and band counts blinded to the physician in charge of the patient)
Allocation to the Lab-score group
|
Control Group
n=117 Participants
Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: white blood cell (WBC) count, band count and C-Reactive Protein (CRP) determination.
(Procalcitonin (PCT) and thus Lab-score blinded to the physician in charge of the patient).
Allocation to the control group
|
|---|---|---|
|
Specificity of Standard Biological Marker for SBI
|
68.8 percentage of patients (specificity)
Interval 62.4 to 75.2
|
79.3 percentage of patients (specificity)
Interval 70.8 to 87.8
|
Adverse Events
Lab-score Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place