Construction and Validation of a Tool for Automatic Identification of Care Pathways At Risk of Sub-optimality in the Management of Severe Infections in Children (DIABACT IV)

NCT ID: NCT02167802

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 524 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-20
• Study Completion Date: 2020-03-07

Brief Summary

Community bacterial infection remains to this day a common cause of morbidity and mortality in children, which preventability is a challenge for clinicians. In a previous work, the investigators found that 76% supported children admitted to the ICU for severe bacterial infection were appraised as suboptimal and significantly associated with an increased risk of death. In this context, the investigators seek to identify indicators of extractable data PMSI and SNIIR -AM associated with a higher risk of suboptimal early taking care of children with severe bacterial infection in order to combine them and use them as a score or decision tree that the investigators will validate data from a national prospective multicenter study including 512 children admitted to the ICU for severe infection. The investigators then propose a score associated with a risk of suboptimality care to evaluate the performance of the healthcare system .

Conditions

Severe Infection

Keywords

severe infection, pediatrics, sub-optimal care, term care

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• All children from 1 month to 15 years and 3 months admitted in pediatric resuscitation;
• Community with severe bacterial infection defined by a bacterial infection documented by the presence of a bacterium from a normally sterile site (pleural cerebrospinal fluid joint fluid, blood, bone biopsy ...), a positive urine culture on a sampling done in aseptic conditions accompanied by a febrile illness (eg pyelonephritis), or purpura fulminans in the absence of documentation.

• Parents and patient (if applicable) who signed the consent biocollection for participation in the substudy.

Exclusion Criteria

• Nosocomial Infections as defined by the Ministry of Health in its January 2007 issue on nosocomial infections namely: Nosocomial infections are infections acquired in a healthcare facility. Infection is considered nosocomial if it was absent at the time of admission of the patient in the health facility. When the infectious status of the patient at admission is unknown, the infection is generally considered nosocomial if it occurs after a period of at least 48 hours of hospitalization or a period longer than the incubation period of the infection. In case of surgical site infection, the period commonly allowed is 30 days, or if it has been set in place a prosthesis or implant, a year after the intervention.
• Children with whooping cough, bronchiolitis or viral infections

• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christèle Gras Le Guen, Pr

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

AP-HP

Paris, France, France

Angers University Hospital

Angers, , France

Olivier Brissaud

Bordeaux, , France

Jacques Sizun

Brest, , France

Thierry Debillon

Grenoble, , France

Stéphane Leteurtre

Lille, , France

Etienne Javouhey

Lyon, , France

Gilles Cambonie

Montpellier, , France

Elise Launay

Nantes, , France

Stéphane Dauger

Paris, , France

Sylvain Renolleau

Paris, , France

Hugues Patural

Saint-Etienne, , France

Countries

France

Other Identifiers

RC14_0119

Identifier Type: -

Identifier Source: org_study_id