Severe InfectionDIABACT IVNCT02167802
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)
An observational study of Severe Infection, run by Nantes University Hospital at 12 sites in France.
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… Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Severe Infection
- How many people
- 524 participants
- Where
- 12 sitesFrance
- Study dates
- 20 Mar 2015to 7 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
- 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.
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Angers University Hospital
Angers, 49933
Olivier Brissaud
Bordeaux, 33076
Jacques Sizun
Brest, 29609
Thierry Debillon
Grenoble, 38043
Stéphane Leteurtre
Lille, 59037
Etienne Javouhey
Lyon, 69003
Gilles Cambonie
Montpellier, 34295
Elise Launay
Nantes, 44093
AP-HP
Paris, France, 75
Stéphane Dauger
Paris, 75000
Sylvain Renolleau
Paris, 75000
Hugues Patural
Saint-Etienne, 42055
About this study
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 .
- Conditions
- Severe Infection
- Keywords
- severe infection, pediatrics, sub-optimal care, term care
- Medical subject headings
- Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (1)
outcome at the hospital discharge defined as death, survival without sequelae and survival with sequelae
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study start20 Mar 2015
- Primary completion7 Mar 2020
- Study completion7 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 524 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christèle Gras Le Guen, Pr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167802
- Sponsor's protocol ID
- RC14_0119
- Acronym
- DIABACT IV
- Status last verified
- Dec 2024
- First submitted
- 7 May 2014
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02167802
- Acronym / sponsor ID
- DIABACT IV / RC14_0119
- Conditions
- Severe Infection
- Keywords
- severe infection, pediatrics, sub-optimal care, term care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 524 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 20 Mar 2015 (actual)
- Primary completion
- 7 Mar 2020 (actual)
- Study completion
- 7 Mar 2020 (actual)
- First posted
- 19 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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.
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcome
outcome at the hospital discharge defined as death, survival without sequelae and survival with sequelae
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christèle Gras Le Guen, Pr principal investigator
Nantes University Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Infection, run by Nantes University Hospital at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the optimality of care questionnaire (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024; AzTrials last refreshed its copy on 30 Oct 2026.