NCT03607162

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,928 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 6 Days – 36 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Fever Without Source

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	DIAFEVER algorithm	PCT rapid test-based predictive algorithm

Timeline

• Start date: 2018-11-01
• Primary completion: 2021-12-03
• Completion: 2021-12-03
• First posted: 2018-07-31
• Last updated: 2021-12-21

Locations

26 sites across 2 countries: France, Switzerland