Fever Without SourceNCT02179398
Impact of the Lab-score on Antibiotic Prescription Rate in Children With Fever Without Source
A study testing Allocation to the Lab-score group in people with Fever Without Source, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 days to 3 years
- Conditions the study is for
- Fever Without Source
- What is being tested?
- Allocation to the Lab-score group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2010to Jul 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 days to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged 7 days to 3 years old
- fever without source ≥ 100.4°F (≥ 38.0°C)
Who cannot join
- antibiotics received in the previous 48 hours
- underlying congenital or acquired immunodeficiency syndrome
- fever for more than 7 days at presentation
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Children's Hospital, Geneva University Hospital
Geneva, Geneva 14, 1211
About this study
Official title: Impact of the Lab-score on Antibiotic Prescription Rate in Children Aged 7 Days to 3 Years Old With Fever Without Source.
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).
- Conditions
- Fever Without Source
- Being tested
- Allocation to the Lab-score group, Allocation to the control group
- Keywords
- Fever without source, Antibiotic prescription, Serious bacterial infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allocation to the Lab-score groupBiological
Allocation to the control groupBiological
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Biological: Allocation to the Lab-score group |
| 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). Receives: Biological: Allocation to the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic Prescription Rate
Measured: at PED (Pediatric Emergency Department) presentation
Secondary outcomes (6)
Presence of Serious Bacterial Infection
Measured: at 72 hours from PED presentation
Hospitalization Rate
Measured: at PED presentation
Sensitivity of a Lab-score ≥ 3
Measured: at 72 hours from PED presentation
Specificity of a Lab-score ≥ 3
Measured: 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
Measured: 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
Measured: at 72 hours from PED presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study startSep 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fever Without SourceStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- BioMérieux
- Responsible party
- Principal investigator, Laurence Lacroix, University Hospital, Geneva
- Investigators
- Laurence E Lacroix, Principal investigator, Children's Hospital, Geneva University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179398
- Sponsor's protocol ID
- 09-162 (MatPed 09-032)
- Status last verified
- Oct 2014
- First submitted
- 27 Jun 2014
- Last updated
- 31 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 18536624Galetto-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.
PubMed 20515973Bressan 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.
PubMed 22760529Lacroix 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.
PubMed 25503770
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Lab-score on Antibiotic Prescription Rate in Children Aged 7 Days to 3 Years Old With Fever Without Source.
- ClinicalTrials.gov ID
- NCT02179398
- Acronym / sponsor ID
- 09-162 (MatPed 09-032)
- Conditions
- Fever Without Source
- Keywords
- Fever without source, Antibiotic prescription, Serious bacterial infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- BioMérieux
- Study start
- Sep 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 1 Jul 2014 (estimated)
- Results
- Posted 31 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lab-score group | Experimental | Biological: Allocation to the Lab-score groupPatients 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 | Biological: Allocation to the control groupPatients 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). |
Who may qualify
- Ages
- 7 days to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children aged 7 days to 3 years old
- fever without source ≥ 100.4°F (≥ 38.0°C)
Key exclusion criteria (3 listed)
- antibiotics received in the previous 48 hours
- underlying congenital or acquired immunodeficiency syndrome
- fever for more than 7 days at presentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allocation to the Lab-score group | Biological | Lab-score group |
| Allocation to the control group | Biological | Control group |
Primary outcome
Antibiotic Prescription Rate
Time frame: at PED (Pediatric Emergency Department) presentation
6 secondary outcomes
Presence of Serious Bacterial Infection
Time frame: at 72 hours from PED presentation
Hospitalization Rate
Time frame: at PED presentation
Sensitivity of a Lab-score ≥ 3
Time frame: at 72 hours from PED presentation
Specificity of a Lab-score ≥ 3
Time frame: at 72 hours from PED presentation
Sensitivity of Standard Biological Marker for SBI
Time frame: at 72 hours from PED presentation
Specificity of Standard Biological Marker for SBI
Time frame: at 72 hours from PED presentation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18536624Lacour 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.
- Background: PubMed 20515973Galetto-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.
- Background: PubMed 22760529Bressan 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.
- Derived from this study: PubMed 25503770Lacroix 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence E Lacroix principal investigator
Children's Hospital, Geneva University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allocation to the Lab-score group in people with Fever Without Source, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibiotic Prescription Rate (time frame: at PED (Pediatric Emergency Department) presentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02179398, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2014.