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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4928 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2021-12-03

Brief Summary

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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

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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

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Fever Without Source

Keywords

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Bacteriemia meningitis Urinary tract infection antibiotic treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

DIAGNOSTIC

PCT rapid test-based predictive algorithm

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

6 Days

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

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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.

Reference Type DERIVED

PMID: 32792425 (View on PubMed)

Other Identifiers

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RC18_0042

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Usual care

DIAFEVER algorithm

DIAFEVER algorithm

Interventions

DIAFEVER algorithm

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Nantes University Hospital

Responsible Party

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

Countries

References

Other Identifiers

RC18_0042