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

NCT03607162 | Completed

• 1 other identifier: RC18_0042
• Study Type: interventional
• Target: 4,928
• Locations: 2 countries
• Sites: 26

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

Conditions

Fever Without Source

Keywords

Bacteriemia; meningitis; Urinary tract infection; antibiotic treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Description of the current epidemiology of FWS among children < 36 months old admitted in an ED

  At inclusion visit

• Diagnostic value of the DIAFEVER prediction rule for SBI and IBI diagnosis

  At inclusion visit

• Impact of the DIAFEVER prediction rule on median length of stay in the ED

  at day 15 after the first ED consultation

• Impact of the DIAFEVER prediction rule on the proportion of children with laboratory tests prescription

  at day 15 after the first ED consultation

• Impact of the DIAFEVER prediction rule on hospitalization rates

  at day 15 after the first ED consultation

Study Arms (2)

Usual care

NO INTERVENTION

Local usual management of FWS (pragmatic approach)

DIAFEVER algorithm

EXPERIMENTAL

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

Diagnostic Test: DIAFEVER algorithm

Interventions

DIAFEVER algorithm DIAGNOSTIC_TEST

PCT rapid test-based predictive algorithm

DIAFEVER algorithm

Eligibility Criteria

• Age: 6 Days - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (26)

University Hospital

Angers, France

Location

University Hospital

Bordeaux, France

Location

University Hospital

Brest, France

Location

University Hospital

Caen, France

Location

AP-HP Antoine Béclère

Clamart, France

Location

University Hospital

Clermont-Ferrand, France

Location

Hopital Louis Mourier

Colombes, France

Location

Centre Hospitalier Intercommunal

Créteil, France

Location

University Hospital

Grenoble, France

Location

CHD Vendée

La Roche-sur-Yon, France

Location

Regional University Hospital

Lille, France

Location

Saint Antoine Saint Vincent Hospital

Lille, France

Location

Southern Bretagne Hospital

Lorient, France

Location

Hospices civils de Lyon

Lyon, France

Location

University Hospital

Montpellier, France

Location

Regional University Hospital

Nancy, France

Location

University Hospital

Nice, France

Location

AP-HP Necker-Enfants Malades

Paris, France

Location

AP-HP Robert Debré

Paris, France

Location

Regional University Hospital

Rennes, France

Location

CHU

Rouen, France

Location

Saint Brieuc Hospital

Saint-Brieuc, France

Location

Chu Saint Etienne

Saint-Etienne, France

Location

University Hospital

Strasbourg, France

Location

University Hospital

Toulouse, France

Location

Hopital des Enfants

Geneva, Switzerland

Location

Related Publications (2)

• Malorey D, Tavernier E, Drouard A, Vrignaud B, Bailhache M, Guyon G, Titomanlio L, Brehin C, Abalea L, Gervaix A, Basmaci R, Dubos F, Tran A, Desgranges M, Launay E, Gras-Leguen C; Diafever Study Group. Point-of-care decision rule for antibiotic prescriptions in young children with fever without source: an open cluster randomised trial. Arch Dis Child. 2025 Dec 17:archdischild-2025-329438. doi: 10.1136/archdischild-2025-329438. Online ahead of print.

  PMID: 41407517 DERIVED

• 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.

  PMID: 32792425 DERIVED

MeSH Terms

Conditions

Meningitis; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases; Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: July 31, 2018
• Study Start: November 1, 2018
• Primary Completion: December 3, 2021
• Study Completion: December 3, 2021
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); FR (25)