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)

Severe Infection Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02167802
• Other study ID #: RC14_0119
• Status: Recruiting
• Start date: March 20, 2015
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: Nantes University Hospital
• Contact: Christèle Gras Le Guen, Pr
• Phone: 02.40.08.76.71
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 782
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Severe Infection

Locations

Country	Name	City	State
France	Angers University Hospital	Angers
France	Olivier Brissaud	Bordeaux
France	Jacques Sizun	Brest
France	Thierry Debillon	GRenoble
France	Stéphane Leteurtre	Lille
France	Etienne Javouhey	Lyon
France	Gilles Cambonie	Montpellier
France	Elise Launay	Nantes
France	AP-HP	Paris
France	Stéphane Dauger	Paris
France	Sylvain Renolleau	Paris
France	Hugues Patural	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	outcome at the hospital discharge defined as death, survival without sequelae and survival with sequelae		1 month