Impact of a PCT(Procalcitonin) Rapid Test -Based Approach on ATB (Antibiotics) Use in Children With Fever Without Source

Fever Without Source Clinical Trial

— DIAFEVER  

Official title:

Impact of a New Sequential Approach on Antimicrobial Use in Young Children With Fever Without Source in Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03607162
• Other study ID #: RC18_0042
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: December 3, 2021

Study information

• Verified date: December 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Fever
• Fever Without Source

Intervention

Diagnostic Test:
• DIAFEVER algorithm
PCT rapid test-based predictive algorithm

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Countries where clinical trial is conducted

France,  Switzerland, 

Outcome

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