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)

Completed

• Conditions: Severe Infection

• Registration Number: NCT02167802
• Lead Sponsor: 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 .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-07
• Study First Submitted QC: 2014-06-18
• Study First Posted: 2014-06-19
• Study Start: 2015-03-20
• Primary Completion: 2020-03-07
• Study Completion: 2020-03-07
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 524

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the optimality of care questionnaire	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

Name	Time	Method
outcome at the hospital discharge defined as death, survival without sequelae and survival with sequelae	1 month

Trial Locations

Locations (12)

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

Stéphane Dauger; 🇫🇷 Paris, France

Sylvain Renolleau; 🇫🇷 Paris, France

AP-HP; 🇫🇷 Paris, France

Hugues Patural; 🇫🇷 Saint-Etienne, France