Fever Without Source Clinical Trial
— DIAFEVEROfficial title:
Impact of a New Sequential Approach on Antimicrobial Use in Young Children With Fever Without Source in Emergency Department
Verified date | December 2021 |
Source | Nantes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Because a newly available point-of-care test may have real interest especially for children in the Emergency Department (ED) setting, by limiting painful and stressful venipunctures and decreasing the length of stay in the ED, the investigators hypothesize that integrating this new capillary Procalcitonin (PCT) rapid test in the DIAFEVER CPR (Clinical Prediction Rules) could represent a highly valuable diagnostic tool to identify a group with low Invasive Bacterial Infection (IBI) risk and could limit unnecessary exams and antibiotic prescriptions. The aim of this present study is to demonstrate the impact of this new PCT rapid-test-based CPR on antibiotic prescription rate in young children with Fever Without Source (FWS) presenting to the ED and on morbidity and mortality
Status | Completed |
Enrollment | 4928 |
Est. completion date | December 3, 2021 |
Est. primary completion date | December 3, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 36 Months |
Eligibility | Inclusion Criteria: - Febrile children aged 6 days to <36 months old presenting to an ED at their initial visit with an acute illness for a maximum of 8 days and diagnosed with a FWS defined as body temperature (measured at home or the ED) > 38°C and a physical examination by a physician without source - Oral non-opposition will be requested from one of the parents or caregivers of the patient. - No current antibiotic treatment or within the 48 hours before the ED presentation. - Parental affiliation with an appropriate health insurance system - Parents speaking French Exclusion Criteria: - A clear source of fever identified after a careful inspection of medical history and a physical examination - No fever on consultation or previously subjectively assessed by parents without use of a thermometer - Refusal of the parents to participate - Child = 36 months or < 6 days old (ie, early-onset neonatal infection) - Ongoing ABT treatment or within the 48 hours before ED presentation - Children with FWS who revisited the ED after their initial visit - Participation with another interventional study involving human subjects or being in the exclusion period at the end of a previous study involving human subjects |
Country | Name | City | State |
---|---|---|---|
France | University Hospital | Angers | |
France | University Hospital | Bordeaux | |
France | University Hospital | Brest | |
France | University Hospital | Caen | |
France | AP-HP Antoine Béclère | Clamart | |
France | University Hospital | Clermont-Ferrand | |
France | Hopital Louis Mourier | Colombes | |
France | Centre Hospitalier Intercommunal | Créteil | |
France | University Hospital | Grenoble | |
France | CHD Vendée | La Roche-sur-Yon | |
France | Regional University Hospital | Lille | |
France | Saint Antoine Saint Vincent Hospital | Lille | |
France | Southern Bretagne Hospital | Lorient | |
France | Hospices civils de Lyon | Lyon | |
France | University Hospital | Montpellier | |
France | Regional University Hospital | Nancy | |
France | University Hospital | Nice | |
France | AP-HP Necker-Enfants Malades | Paris | |
France | AP-HP Robert Debré | Paris | |
France | Regional University Hospital | Rennes | |
France | CHU | Rouen | |
France | Saint Brieuc Hospital | Saint-Brieuc | |
France | Chu Saint Etienne | Saint-Étienne | |
France | University Hospital | Strasbourg | |
France | University Hospital | Toulouse | |
Switzerland | Hopital des Enfants | Geneva |
Lead Sponsor | Collaborator |
---|---|
Nantes University Hospital |
France, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in antibiotics exposure | Related to the superiority objective : change in antibiotics exposure based on the proportion of children who received ABT | at day 15 after the first ED consultation | |
Secondary | Description of the current epidemiology of FWS among children < 36 months old admitted in an ED | The incidence of FWS among children admitted in EDs, the incidence of Severe Bacterial Infection (SBI) and IBI among the children admitted in the ED with FWS | At inclusion visit | |
Secondary | Diagnostic value of the DIAFEVER prediction rule for SBI and IBI diagnosis | Assessment of sensitivity, specificity, predictive values, Likelihood Ratio, of the DIAFEVER prediction rule (combining high- and intermediate-risk versus low-risk populations) considering the SBI/IBI diagnosis as the gold standard | At inclusion visit | |
Secondary | Impact of the DIAFEVER prediction rule on median length of stay in the ED | at day 15 after the first ED consultation | ||
Secondary | Impact of the DIAFEVER prediction rule on the proportion of children with laboratory tests prescription | at day 15 after the first ED consultation | ||
Secondary | Impact of the DIAFEVER prediction rule on hospitalization rates | at day 15 after the first ED consultation | ||
Secondary | vaccine coverage of children consulting for FWS evaluated by the vaccination coverage rate (among children with FWS) | at day 15 after the first ED consultation | ||
Secondary | theoretically vaccine-preventable SBI | theoretically vaccine-preventable SBI is defined as an infection with an identified serotype included in the national vaccine schedule and occurring in a child with untimely vaccination | at day 15 after the first ED consultation | |
Secondary | morbidity and mortality | Morbidity and mortality based on a binary composite outcome considering occurrence or not during the 15 days after discharge from the ED of one of the following events:
death intensive care unit admission for any reason disease-specific complications (ie, cerebral damage with neurologic impairment, deathless, blindness amputation, cutaneous necrosis requiring surgery, definitive renal failure etc.) diagnosis of Invasive Bacterial Infection or Serious Bacterial Infection |
at day 15 after the first ED consultation |
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