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

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ClinicalTrials.gov Identifier: NCT02179398
Recruitment Status : Completed
First Posted : July 1, 2014
Results First Posted : October 31, 2014
Last Update Posted : October 31, 2014
Sponsor:
Collaborator:
BioMérieux
Information provided by (Responsible Party):
Laurence Lacroix, University Hospital, Geneva

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Fever Without Source
Interventions Biological: Allocation to the Lab-score group
Biological: Allocation to the control group
Enrollment 278
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lab-score Group Control Group
Hide Arm/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)

Allocation to the Lab-score 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

Period Title: Overall Study
Started 134 144
Completed 131 140
Not Completed 3 4
Reason Not Completed
Lack of obligatory data             3             3
Lost to Follow-up             0             1
Arm/Group Title Lab-score Group Control Group Total
Hide Arm/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)

Allocation to the Lab-score 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

Total of all reporting groups
Overall Number of Baseline Participants 131 140 271
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Months
Number Analyzed 131 participants 140 participants 271 participants
4.8
(1.7 to 10.4)
3.4
(1.5 to 10.4)
4.0
(1.6 to 10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 140 participants 271 participants
Female
66
  50.4%
69
  49.3%
135
  49.8%
Male
65
  49.6%
71
  50.7%
136
  50.2%
Fever duration  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 131 participants 140 participants 271 participants
< 12 hours 47 55 102
12-24 hours 25 24 49
> 24 hours 59 61 120
Maximum temperature  
Mean (Standard Deviation)
Unit of measure:  °C
Number Analyzed 131 participants 140 participants 271 participants
39.3  (0.8) 39.3  (0.8) 39.3  (0.78)
Lab-score value   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 131 participants 140 participants 271 participants
2.03  (2.62) 2.04  (2.86) 2.04  (2.74)
[1]
Measure Description: Lab-score value ranges from 0 to 9. A cutoff point ≥3 was identified as the best Lab-score value for SBI prediction in the original derivation study. A child with a Lab-score < 3 has a low SBI risk, whereas a child with a Lab-score value ≥3 has a high >SBI risk.
Presence of Serious Bacterial Infection (SBI)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 131 participants 140 participants 271 participants
32 35 67
[1]
Measure Description: SBI was defined as isolation of a bacterial pathogen from the blood, the urine, the cerebrospinal fluid, the synovial fluid, the bone, the stools, or by presence of pneumonia (defined as presence of fever, ≥38°C or ≥100.4°F, cough, tachypnea, and a radiographic lung infiltrate).
1.Primary Outcome
Title Antibiotic Prescription Rate
Hide Description [Not Specified]
Time Frame at PED (Pediatric Emergency Department) presentation
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lab-score Group Control Group
Hide Arm/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.

(white blood cell (WBC) and band counts blinded to the physician in charge of the patient)

Allocation to the Lab-score group

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

Overall Number of Participants Analyzed 131 140
Measure Type: Number
Unit of Measure: participants
54 59
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lab-score Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Presence of Serious Bacterial Infection
Hide Description [Not Specified]
Time Frame at 72 hours from PED presentation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lab-score Group Control Group
Hide Arm/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)

Allocation to the Lab-score 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 Number of Participants Analyzed 131 140
Measure Type: Number
Unit of Measure: participants
32 35
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lab-score Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Hospitalization Rate
Hide Description [Not Specified]
Time Frame at PED presentation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lab-score Group Control Group
Hide Arm/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)

Allocation to the Lab-score 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 Number of Participants Analyzed 131 140
Measure Type: Number
Unit of Measure: participants
44 50
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lab-score Group, Control Group
Comments 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 rate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.810
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Sensitivity of a Lab-score ≥ 3
Hide Description [Not Specified]
Time Frame at 72 hours from PED presentation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients 0-3 Years Old Patients < 3 Months Old
Hide Arm/Group Description:
Patients allocated to the Lab-score group OR to the control group, aged 0 up to 36 months-old.
Patients allocated to the Lab-score group OR to the control group, aged less than 3 months-old.
Overall Number of Participants Analyzed 271 117
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients (sensitivity)
85.1
(76.5 to 93.6)
80.0
(65.7 to 94.3)
5.Secondary Outcome
Title Specificity of a Lab-score ≥ 3
Hide Description [Not Specified]
Time Frame at 72 hours from PED presentation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients 0-3 Years Old Patients < 3 Months Old
Hide Arm/Group Description:
Patients allocated to the Lab-score group OR to the control group, aged 0 up to 36 months-old.
Patients allocated to the Lab-score group OR to the control group, aged less than 3 months-old.
Overall Number of Participants Analyzed 271 117
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients (specificity)
87.3
(82.7 to 91.8)
93.1
(87.8 to 98.4)
6.Secondary Outcome
Title Sensitivity of Standard Biological Marker for SBI
Hide Description Sensitivity of standard biological marker for SBI: WBC ≥ 15’000/mm³ and/or bands ≥ 1’500/mm³ and/or CRP ≥ 40 mg/L
Time Frame at 72 hours from PED presentation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients 0-3 Years Old Patients < 3 Months Old
Hide Arm/Group Description:
Patients allocated to the Lab-score group OR to the control group, aged 0 up to 36 months-old.
Patients allocated to the Lab-score group OR to the control group, aged less than 3 months-old.
Overall Number of Participants Analyzed 271 117
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients (sensitivity)
83.6
(74.7 to 92.5)
70.0
(53.6 to 86.4)
7.Secondary Outcome
Title Specificity of Standard Biological Marker for SBI
Hide Description Specificity of standard biological marker for SBI: WBC ≥ 15'000/mm³ and/or bands ≥ 1’500/mm³ and/or CRP ≥ 40 mg/L
Time Frame at 72 hours from PED presentation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients 0-3 Years Old Patients < 3 Months Old
Hide Arm/Group Description:
Patients allocated to the Lab-score group OR to the control group, aged 0 up to 36 months-old.
Patients allocated to the Lab-score group OR to the control group, aged less than 3 months-old.
Overall Number of Participants Analyzed 271 117
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients (specificity)
68.8
(62.4 to 75.2)
79.3
(70.8 to 87.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lab-score Group Control Group
Hide Arm/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)

Allocation to the Lab-score 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

All-Cause Mortality
Lab-score Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lab-score Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/131 (0.00%)   0/140 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lab-score Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/131 (0.00%)   0/140 (0.00%) 
  • heterogeneity in the total number of participating physicians (30)
  • recruitment in a tertiary care center (recruitment bias)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Laurence Lacroix
Organization: Geneva University Hospital
Phone: +41223725082
Responsible Party: Laurence Lacroix, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02179398     History of Changes
Other Study ID Numbers: 09-162 (MatPed 09-032)
First Submitted: June 27, 2014
First Posted: July 1, 2014
Results First Submitted: October 21, 2014
Results First Posted: October 31, 2014
Last Update Posted: October 31, 2014