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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)

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ClinicalTrials.gov Identifier: NCT02167802
Recruitment Status : Recruiting
First Posted : June 19, 2014
Last Update Posted : February 1, 2019
Sponsor:
Collaborator:
Inserm U953, Paris
Information provided by (Responsible Party):
Nantes University Hospital

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 .

Condition or disease
Severe Infection

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Study Type : Observational
Estimated Enrollment : 782 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : March 20, 2015
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020



Primary Outcome Measures :
  1. the optimality of care questionnaire [ Time Frame: 1 month ]
    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


Secondary Outcome Measures :
  1. outcome at the hospital discharge defined as death, survival without sequelae and survival with sequelae [ Time Frame: 1 month ]


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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02167802


Contacts
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Contact: Christèle Gras Le Guen, Pr 02.40.08.76.71

Locations
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France
Angers University Hospital Recruiting
Angers, France, 49933
Contact: Gérald BOUSSICAULT, Dr         
Principal Investigator: Gérald BOUSSICAULT, Dr         
Olivier Brissaud Active, not recruiting
Bordeaux, France, 33076
Jacques Sizun Recruiting
Brest, France, 29609
Contact: Jacques Sizun, Pr       jacques.sizun@chu-brest.fr   
Principal Investigator: Jacques Sizun, Pr         
Thierry Debillon Recruiting
GRenoble, France, 38043
Contact: Thierry Debillon, Pr       tdebillon@chu-grenoble.fr   
Principal Investigator: Thierry Debillon         
Stéphane Leteurtre Recruiting
Lille, France, 59037
Contact: Stéphane Leteurtre, Pr       stephane.leteurtre@chru-lille.fr   
Principal Investigator: Stéphane Leteurtre, Pr         
Etienne Javouhey Recruiting
Lyon, France, 69003
Contact: Etienne Javouhey, Pr       etienne.javouhey@chu-lyon.fr   
Principal Investigator: Etienne Javouhey, Pr         
Gilles Cambonie Recruiting
Montpellier, France, 34295
Contact: Gilles Cambonie, Pr       g-cambonie@chu-montpellier.fr   
Principal Investigator: Gilles Cambonie, Pr         
Elise Launay Recruiting
Nantes, France, 44093
Contact: Elise Launay, Dr       elise.launay@chu-nantes.fr   
Principal Investigator: Elise Launay, Dr         
Stéphane Dauger Recruiting
Paris, France, 75000
Contact: Stéphane Dauger       stephane.dauger@rdb.aphp.fr   
Principal Investigator: Stéphane Dauger, Pr         
Sylvain Renolleau Recruiting
Paris, France, 75000
Contact: Sylvain Renolleau, Pr       sylvain.renolleau@trs.aphp.fr   
Principal Investigator: Sylvain Renolleau, Pr         
AP-HP Recruiting
Paris, France, 75
Contact: Philippe HUBERT, Pr         
Principal Investigator: Philippe HUBERT, Pr         
Hugues Patural Not yet recruiting
Saint-Etienne, France, 42055
Contact: Hugues Patural, Pr       hugues.patural@chu-st-etienne.fr   
Principal Investigator: Hugues Patural, Pr         
Sponsors and Collaborators
Nantes University Hospital
Inserm U953, Paris
Investigators
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Principal Investigator: Christèle Gras Le Guen, Pr Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02167802     History of Changes
Other Study ID Numbers: RC14_0119
First Posted: June 19, 2014    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019

Keywords provided by Nantes University Hospital:
severe infection, pediatrics, sub-optimal care, term care

Additional relevant MeSH terms:
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Infection
Communicable Diseases