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)
DIABACT IV
1 other identifier
observational
524
1 country
12
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2015
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2014
CompletedFirst Posted
Study publicly available on registry
June 19, 2014
CompletedStudy Start
First participant enrolled
March 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 7, 2020
CompletedDecember 10, 2024
December 1, 2024
5 years
May 7, 2014
December 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the optimality of care questionnaire
optimality of care will be assessed by 2 independent experts, blinded to outcome and final diagnosis. Medical charts will be summarized and given to experts without outcome or diagnosis. They would be asked to evaluate optimality of care as follow: optimal, certainly sub-optimal, possibly suboptimal and not evaluable
1 month
Secondary Outcomes (1)
outcome at the hospital discharge defined as death, survival without sequelae and survival with sequelae
1 month
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
AP-HP
Paris, France, 75, France
Angers University Hospital
Angers, 49933, France
Olivier Brissaud
Bordeaux, 33076, France
Jacques Sizun
Brest, 29609, France
Thierry Debillon
Grenoble, 38043, France
Stéphane Leteurtre
Lille, 59037, France
Etienne Javouhey
Lyon, 69003, France
Gilles Cambonie
Montpellier, 34295, France
Elise Launay
Nantes, 44093, France
Stéphane Dauger
Paris, 75000, France
Sylvain Renolleau
Paris, 75000, France
Hugues Patural
Saint-Etienne, 42055, France
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Christèle Gras Le Guen, Pr
Nantes University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2014
First Posted
June 19, 2014
Study Start
March 20, 2015
Primary Completion
March 7, 2020
Study Completion
March 7, 2020
Last Updated
December 10, 2024
Record last verified: 2024-12