Impact of a PCT(Procalcitonin) Rapid Test -Based Approach on ATB (Antibiotics) Use in Children With Fever Without Source
- Conditions
- Fever Without Source
- Interventions
- Diagnostic Test: DIAFEVER algorithm
- Registration Number
- NCT03607162
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4928
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description DIAFEVER algorithm DIAFEVER algorithm New DIAFEVER sequential algorithm PCT rapid test-based will be applied
- Primary Outcome Measures
Name Time Method Change in antibiotics exposure at day 15 after the first ED consultation Related to the superiority objective : change in antibiotics exposure based on the proportion of children who received ABT
- Secondary Outcome Measures
Name Time Method Impact of the DIAFEVER prediction rule on median length of stay in the ED at day 15 after the first ED consultation Impact of the DIAFEVER prediction rule on hospitalization rates at day 15 after the first ED consultation Description of the current epidemiology of FWS among children < 36 months old admitted in an ED At inclusion visit 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
morbidity and mortality at day 15 after the first ED consultation 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 InfectionDiagnostic value of the DIAFEVER prediction rule for SBI and IBI diagnosis At inclusion visit 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
Impact of the DIAFEVER prediction rule on the proportion of children with laboratory tests prescription 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) at day 15 after the first ED consultation theoretically vaccine-preventable SBI at day 15 after the first ED consultation 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
Trial Locations
- Locations (15)
University Hospital
🇫🇷Toulouse, France
AP-HP Antoine Béclère
🇫🇷Clamart, France
Hopital Louis Mourier
🇫🇷Colombes, France
Centre Hospitalier Intercommunal
🇫🇷Créteil, France
Saint Antoine Saint Vincent Hospital
🇫🇷Lille, France
CHD Vendée
🇫🇷La Roche-sur-Yon, France
Regional University Hospital
🇫🇷Rennes, France
Southern Bretagne Hospital
🇫🇷Lorient, France
AP-HP Necker-Enfants Malades
🇫🇷Paris, France
AP-HP Robert Debré
🇫🇷Paris, France
CHU
🇫🇷Rouen, France
Saint Brieuc Hospital
🇫🇷Saint-Brieuc, France
Chu Saint Etienne
🇫🇷Saint-Étienne, France
Hopital des Enfants
🇨🇭Geneva, Switzerland
Hospices civils de Lyon
🇫🇷Lyon, France