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
This prospective multicentric randomized study will include 5000 febrile children aged six days to three years, diagnosed with fever without source, in 26 participating French and Swiss emergency departments, during a 36-month period. During one period, all children will receive usual care. In a second period, the DIAFEVER algorithm will be applied in half of the clusters, and in the remaining clusters, children will still receive usual care. Then in the last period of one year, all centers will apply the new PCT-based algorithm. At day 15 after the first consultation, data concerning death, intensive care unit admission, disease-specific complications, diagnosis of bacterial infections and proportion of antibiotic treatments will be assessed by questioning parents by use of an online electronic case report form or a phone call. The endpoints will be compared between the two groups by using a mixed logistic regression model adjusted on clustering of participants within centers and period within centers. To perform complementary studies, a biocollection will be proposed to parents when blood tests will be indicated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
4,928
PCT rapid test-based predictive algorithm
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
...and 16 more locations
Change in antibiotics exposure
Related to the superiority objective : change in antibiotics exposure based on the proportion of children who received ABT
Time frame: at day 15 after the first ED consultation
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
Time frame: At inclusion visit
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
Time frame: At inclusion visit
Impact of the DIAFEVER prediction rule on median length of stay in the ED
Time frame: at day 15 after the first ED consultation
Impact of the DIAFEVER prediction rule on the proportion of children with laboratory tests prescription
Time frame: at day 15 after the first ED consultation
Impact of the DIAFEVER prediction rule on hospitalization rates
Time frame: at day 15 after the first ED consultation
vaccine coverage of children consulting for FWS evaluated by the vaccination coverage rate (among children with FWS)
Time frame: at day 15 after the first ED consultation
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
Time frame: at day 15 after the first ED consultation
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
Time frame: at day 15 after the first ED consultation
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