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Completed

NCT Number: 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)

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 .

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Key information

Age range

Up to 15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AP-HP, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  1. outcome at the hospital discharge defined as death, survival without sequelae and survival with sequelae

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: DIABACT IV

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jun 19, 2014
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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