Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| BioMérieux | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lab-score group | Experimental | 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) |
|
| Control group | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allocation to the Lab-score group | Biological |
| ||
| Allocation to the control group |
| Measure | Description | Time Frame |
|---|---|---|
| Antibiotic Prescription Rate | at PED (Pediatric Emergency Department) presentation |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Serious Bacterial Infection | at 72 hours from PED presentation | |
| Hospitalization Rate | at PED presentation | |
| Sensitivity of a Lab-score ≥ 3 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laurence E Lacroix | Children's Hospital, Geneva University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital, Geneva University Hospital | Geneva | Geneva 14 | 1211 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18536624 | Background | Lacour AG, Zamora SA, Gervaix A. A score identifying serious bacterial infections in children with fever without source. Pediatr Infect Dis J. 2008 Jul;27(7):654-6. doi: 10.1097/INF.0b013e318168d2b4. | |
| 20515973 | Background | Galetto-Lacour A, Zamora SA, Andreola B, Bressan S, Lacroix L, Da Dalt L, Gervaix A. Validation of a laboratory risk index score for the identification of severe bacterial infection in children with fever without source. Arch Dis Child. 2010 Dec;95(12):968-73. doi: 10.1136/adc.2009.176800. Epub 2010 Jun 1. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Antibiotic Prescription Rate | 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 | Posted | Number | participants | at PED (Pediatric Emergency Department) presentation |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Laurence Lacroix | Geneva University Hospital | +41223725082 | laurence.lacroix@hcuge.ch |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Biological |
|
| at 72 hours from PED presentation |
| Specificity of a Lab-score ≥ 3 | at 72 hours from PED presentation |
| Sensitivity of Standard Biological Marker for SBI | Sensitivity of standard biological marker for SBI: WBC ≥ 15'000/mm³ and/or bands ≥ 1'500/mm³ and/or CRP ≥ 40 mg/L | at 72 hours from PED presentation |
| Specificity of Standard Biological Marker for SBI | Specificity of standard biological marker for SBI: WBC ≥ 15'000/mm³ and/or bands ≥ 1'500/mm³ and/or CRP ≥ 40 mg/L | at 72 hours from PED presentation |
| 22760529 | Background | Bressan S, Gomez B, Mintegi S, Da Dalt L, Blazquez D, Olaciregui I, de la Torre M, Palacios M, Berlese P, Ruano A. Diagnostic performance of the lab-score in predicting severe and invasive bacterial infections in well-appearing young febrile infants. Pediatr Infect Dis J. 2012 Dec;31(12):1239-44. doi: 10.1097/INF.0b013e318266a9aa. |
| 25503770 | Derived | Lacroix L, Manzano S, Vandertuin L, Hugon F, Galetto-Lacour A, Gervaix A. Impact of the lab-score on antibiotic prescription rate in children with fever without source: a randomized controlled trial. PLoS One. 2014 Dec 11;9(12):e115061. doi: 10.1371/journal.pone.0115061. eCollection 2014. |
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 |
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Fever duration | Number | participants |
|
| Maximum temperature | Mean | Standard Deviation | °C |
|
| Lab-score value | 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. | Mean | Standard Deviation | units on a scale |
|
| Presence of Serious Bacterial Infection (SBI) | 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). | Number | participants |
|
|
|
|
| Secondary | Presence of Serious Bacterial Infection | Posted | Number | participants | at 72 hours from PED presentation |
|
|
|
|
| Secondary | Hospitalization Rate | Posted | Number | participants | at PED presentation |
|
|
|
|
| Secondary | Sensitivity of a Lab-score ≥ 3 | Posted | Number | 95% Confidence Interval | percentage of patients (sensitivity) | at 72 hours from PED presentation |
|
|
|
| Secondary | Specificity of a Lab-score ≥ 3 | Posted | Number | 95% Confidence Interval | percentage of patients (specificity) | at 72 hours from PED presentation |
|
|
|
| Secondary | Sensitivity of Standard Biological Marker for SBI | Sensitivity of standard biological marker for SBI: WBC ≥ 15'000/mm³ and/or bands ≥ 1'500/mm³ and/or CRP ≥ 40 mg/L | Posted | Number | 95% Confidence Interval | percentage of patients (sensitivity) | at 72 hours from PED presentation |
|
|
|
| Secondary | Specificity of Standard Biological Marker for SBI | Specificity of standard biological marker for SBI: WBC ≥ 15'000/mm³ and/or bands ≥ 1'500/mm³ and/or CRP ≥ 40 mg/L | Posted | Number | 95% Confidence Interval | percentage of patients (specificity) | at 72 hours from PED presentation |
|
|
|
| 0 |
| 131 |
| 0 |
| 131 |
| EG001 | 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 | 0 | 140 | 0 | 140 |
Not provided
Not provided