Clinical trial NCT03607162: Impact of a PCT(Procalcitonin) Rapid Test -Based Approach on ATB (Antibiotics) Use in Children With Fever Without Source
Official title: Impact of a New Sequential Approach on Antimicrobial Use in Young Children With Fever Without Source in Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fever Without Source
Keywords: Bacteriemia
meningitis
Urinary tract infection
antibiotic treatment
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 4928
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is an open cluster randomized clinical trial with random and sequential crossover of clusters from control to intervention until all clusters are exposed. Clusters are defined as EDs.

2 periods will be considered, one when all children will receive usual care, whatever the cluster, and a second one when, in half of the clusters, the DIAFEVER algorithm will be applied, and in the remaining clusters, children will still receive usual care.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in antibiotics exposure
timeFrame: at day 15 after the first ED consultation
Secondary outcomes:
measure: Description of the current epidemiology of FWS among children < 36 months old admitted in an ED
timeFrame: At inclusion visit
measure: Diagnostic value of the DIAFEVER prediction rule for SBI and IBI diagnosis
timeFrame: At inclusion visit
measure: Impact of the DIAFEVER prediction rule on median length of stay in the ED
timeFrame: at day 15 after the first ED consultation
measure: Impact of the DIAFEVER prediction rule on the proportion of children with laboratory tests prescription
timeFrame: at day 15 after the first ED consultation
measure: Impact of the DIAFEVER prediction rule on hospitalization rates
timeFrame: at day 15 after the first ED consultation
measure: vaccine coverage of children consulting for FWS evaluated by the vaccination coverage rate (among children with FWS)
timeFrame: at day 15 after the first ED consultation
measure: theoretically vaccine-preventable SBI
timeFrame: at day 15 after the first ED consultation
measure: morbidity and mortality
timeFrame: at day 15 after the first ED consultation
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
city: Bordeaux
country: France
facility: University Hospital
city: Brest
country: France
facility: University Hospital
city: Caen
country: France
facility: University Hospital
city: Clamart
country: France
facility: AP-HP Antoine Béclère
city: Clermont-Ferrand
country: France
facility: University Hospital
city: Colombes
country: France
facility: Hopital Louis Mourier
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal
city: Grenoble
country: France
facility: University Hospital
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: Lille
country: France
facility: Regional University Hospital
city: Lille
country: France
facility: Saint Antoine Saint Vincent Hospital
city: Lorient
country: France
facility: Southern Bretagne Hospital
city: Lyon
country: France
facility: Hospices civils de Lyon
city: Montpellier
country: France
facility: University Hospital
city: Nancy
country: France
facility: Regional University Hospital
city: Nice
country: France
facility: University Hospital
city: Paris
country: France
facility: AP-HP Necker-Enfants Malades
city: Paris
country: France
facility: AP-HP Robert Debré
city: Rennes
country: France
facility: Regional University Hospital
city: Rouen
country: France
facility: CHU
city: Saint-Brieuc
country: France
facility: Saint Brieuc Hospital
city: Saint-Étienne
country: France
facility: Chu Saint Etienne
city: Strasbourg
country: France
facility: University Hospital
city: Toulouse
country: France
facility: University Hospital
city: Geneva
country: Switzerland
facility: Hopital des Enfants
Study officials:
References:
citation: Hubert G, Launay E, Feildel Fournial C, Chauvire-Drouard A, Lorton F, Tavernier E, Giraudeau B, Gras Le Guen C. Assessment of the impact of a new sequential approach to antimicrobial use in young febrile children in the emergency department (DIAFEVERCHILD): a French prospective multicentric controlled, open, cluster-randomised, parallel-group study protocol. BMJ Open. 2020 Aug 13;10(8):e034828. doi: 10.1136/bmjopen-2019-034828.