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

Primary Purpose

Fever Without Source

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
DIAFEVER algorithm
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Fever Without Source focused on measuring Bacteriemia, meningitis, Urinary tract infection, antibiotic treatment

Eligibility Criteria

6 Days - 36 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital
  • University Hospital
  • University Hospital
  • University Hospital
  • AP-HP Antoine Béclère
  • University Hospital
  • Hopital Louis Mourier
  • Centre Hospitalier Intercommunal
  • University Hospital
  • CHD Vendée
  • Regional University Hospital
  • Saint Antoine Saint Vincent Hospital
  • Southern Bretagne Hospital
  • Hospices civils de Lyon
  • University Hospital
  • Regional University Hospital
  • University Hospital
  • AP-HP Necker-Enfants Malades
  • AP-HP Robert Debré
  • Regional University Hospital
  • CHU
  • Saint Brieuc Hospital
  • Chu Saint Etienne
  • University Hospital
  • University Hospital
  • Hopital des Enfants

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

DIAFEVER algorithm

Arm Description

Local usual management of FWS (pragmatic approach)

New DIAFEVER sequential algorithm PCT rapid test-based will be applied

Outcomes

Primary Outcome Measures

Change in antibiotics exposure
Related to the superiority objective : change in antibiotics exposure based on the proportion of children who received ABT

Secondary Outcome Measures

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
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
Impact of the DIAFEVER prediction rule on median length of stay in the ED
Impact of the DIAFEVER prediction rule on the proportion of children with laboratory tests prescription
Impact of the DIAFEVER prediction rule on hospitalization rates
vaccine coverage of children consulting for FWS evaluated by the vaccination coverage rate (among children with FWS)
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
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

Full Information

First Posted
July 10, 2018
Last Updated
December 20, 2021
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03607162
Brief Title
Impact of a PCT(Procalcitonin) Rapid Test -Based Approach on ATB (Antibiotics) Use in Children With Fever Without Source
Acronym
DIAFEVER
Official Title
Impact of a New Sequential Approach on Antimicrobial Use in Young Children With Fever Without Source in Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
December 3, 2021 (Actual)
Study Completion Date
December 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever Without Source
Keywords
Bacteriemia, meningitis, Urinary tract infection, antibiotic treatment

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Participant
Allocation
Randomized
Enrollment
4928 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Local usual management of FWS (pragmatic approach)
Arm Title
DIAFEVER algorithm
Arm Type
Experimental
Arm Description
New DIAFEVER sequential algorithm PCT rapid test-based will be applied
Intervention Type
Diagnostic Test
Intervention Name(s)
DIAFEVER algorithm
Intervention Description
PCT rapid test-based predictive algorithm
Primary Outcome Measure Information:
Title
Change in antibiotics exposure
Description
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
Secondary Outcome Measure Information:
Title
Description of the current epidemiology of FWS among children < 36 months old admitted in an ED
Description
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
Title
Diagnostic value of the DIAFEVER prediction rule for SBI and IBI diagnosis
Description
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
Title
Impact of the DIAFEVER prediction rule on median length of stay in the ED
Time Frame
at day 15 after the first ED consultation
Title
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
Title
Impact of the DIAFEVER prediction rule on hospitalization rates
Time Frame
at day 15 after the first ED consultation
Title
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
Title
theoretically vaccine-preventable SBI
Description
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
Title
morbidity and mortality
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Days
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University Hospital
City
Angers
Country
France
Facility Name
University Hospital
City
Bordeaux
Country
France
Facility Name
University Hospital
City
Brest
Country
France
Facility Name
University Hospital
City
Caen
Country
France
Facility Name
AP-HP Antoine Béclère
City
Clamart
Country
France
Facility Name
University Hospital
City
Clermont-Ferrand
Country
France
Facility Name
Hopital Louis Mourier
City
Colombes
Country
France
Facility Name
Centre Hospitalier Intercommunal
City
Créteil
Country
France
Facility Name
University Hospital
City
Grenoble
Country
France
Facility Name
CHD Vendée
City
La Roche-sur-Yon
Country
France
Facility Name
Regional University Hospital
City
Lille
Country
France
Facility Name
Saint Antoine Saint Vincent Hospital
City
Lille
Country
France
Facility Name
Southern Bretagne Hospital
City
Lorient
Country
France
Facility Name
Hospices civils de Lyon
City
Lyon
Country
France
Facility Name
University Hospital
City
Montpellier
Country
France
Facility Name
Regional University Hospital
City
Nancy
Country
France
Facility Name
University Hospital
City
Nice
Country
France
Facility Name
AP-HP Necker-Enfants Malades
City
Paris
Country
France
Facility Name
AP-HP Robert Debré
City
Paris
Country
France
Facility Name
Regional University Hospital
City
Rennes
Country
France
Facility Name
CHU
City
Rouen
Country
France
Facility Name
Saint Brieuc Hospital
City
Saint-Brieuc
Country
France
Facility Name
Chu Saint Etienne
City
Saint-Étienne
Country
France
Facility Name
University Hospital
City
Strasbourg
Country
France
Facility Name
University Hospital
City
Toulouse
Country
France
Facility Name
Hopital des Enfants
City
Geneva
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32792425
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.
Results Reference
derived

Learn more about this trial

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

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