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NCT03607162: DIAFEVER

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

Completed NA Last updated 21 December 2021
What this trial tests

NA trial testing DIAFEVER algorithm in Fever Without Source in 4,928 participants. Completed in 3 December 2021.

Timeline
1 November 2018
Primary endpoint
3 December 2021
3 December 2021

Quick facts

Lead sponsorNantes University Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposediagnostic
Enrollment4,928
Start date1 November 2018
Primary completion3 December 2021
Estimated completion3 December 2021
Sites26 locations across France, Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

Nantes University Hospital

Who can join

Adults 6 Days to 36 Months, any sex, with Fever Without Source. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. 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.
    Hubert G, Launay E, Feildel Fournial C, Chauvire-Drouard A, et al · · 2020 · cited 3× · PMID 32792425 · DOI 10.1136/bmjopen-2019-034828
  2. Point-of-care decision rule for antibiotic prescriptions in young children with fever without source: an open cluster randomised trial.
    Malorey D, Tavernier E, Drouard A, Vrignaud B, et al · · 2026 · PMID 41407517 · DOI 10.1136/archdischild-2025-329438

Verify or expand the search:

Other recruiting trials for Fever Without Source

Currently open trials in the same condition.

Other Nantes University Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03607162.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing