Clinical trial NCT02167802: 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)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Infection
Keywords: severe infection, pediatrics, sub-optimal care, term care
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2014-06-19
Enrollment: 524
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients included in this study will be children admitted to pediatric intensive care unit for a severe bacterial infection community.

Retrospective inclusions (data DIABACT III study) of children from 1 month to 15 years and 3 months and prospective inclusions concern for children from 0 months to 15 years and 3 months.

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 .


Eligibility criteria: Inclusion Criteria for retrospective inclusions:

* 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.

Inclusion Criteria for prospective inclusions:

* The inclusion criteria DIABACT III will be expanded to include children 0-1 months.
* 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

Primary outcomes:
measure: the optimality of care questionnaire
timeFrame: 1 month
Secondary outcomes:
measure: outcome at the hospital discharge defined as death, survival without sequelae and survival with sequelae
timeFrame: 1 month
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Bordeaux
country: France
facility: Olivier Brissaud
city: Brest
country: France
facility: Jacques Sizun
city: GRenoble
country: France
facility: Thierry Debillon
city: Lille
country: France
facility: Stéphane Leteurtre
city: Lyon
country: France
facility: Etienne Javouhey
city: Montpellier
country: France
facility: Gilles Cambonie
city: Nantes
country: France
facility: Elise Launay
city: Paris
country: France
facility: Stéphane Dauger
city: Paris
country: France
facility: Sylvain Renolleau
city: Paris
country: France
facility: AP-HP
city: Saint-Etienne
country: France
facility: Hugues Patural
Study officials:
affiliation: Nantes University Hospital
name: Christèle Gras Le Guen, Pr
role: PRINCIPAL_INVESTIGATOR
References: