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)

August 3, 2023 updated by: Nantes University Hospital
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 .

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

782

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Christèle Gras Le Guen, Pr
  • Phone Number: 02.40.08.76.71

Study Locations

  • France
      • Angers, France, 49933
        • Recruiting
        • Angers University Hospital
        • Contact:
          • Gérald BOUSSICAULT, Dr
        • Principal Investigator:
          • Gérald BOUSSICAULT, Dr
      • Bordeaux, France, 33076
        • Active, not recruiting
        • Olivier Brissaud
      • Brest, France, 29609
      • GRenoble, France, 38043
        • Recruiting
        • Thierry Debillon
        • Contact:
        • Principal Investigator:
          • Thierry Debillon
      • Lille, France, 59037
      • Lyon, France, 69003
        • Recruiting
        • Etienne Javouhey
        • Contact:
        • Principal Investigator:
          • Etienne Javouhey, Pr
      • Montpellier, France, 34295
      • Nantes, France, 44093
      • Paris, France, 75000
        • Recruiting
        • Stéphane Dauger
        • Contact:
        • Principal Investigator:
          • Stéphane Dauger, Pr
      • Paris, France, 75000
      • Paris, France, 75
        • Recruiting
        • AP-HP
        • Contact:
          • Philippe HUBERT, Pr
        • Principal Investigator:
          • Philippe HUBERT, Pr
      • Saint-Etienne, France, 42055

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 15 years (Child)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
outcome at the hospital discharge defined as death, survival without sequelae and survival with sequelae
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Christèle Gras Le Guen, Pr, Nantes university hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2015

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

May 7, 2014

First Submitted That Met QC Criteria

June 18, 2014

First Posted (Estimated)

June 19, 2014

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC14_0119

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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