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Retrospective Examination of Initial Care of Severe Bacterial Infections of the Child

Frequency, Consequences and Determinants of Sub-optimal Care in the Initial Care of Severe Bacterial Infections of the Child

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01485705
Acronym
Diabact
Enrollment
371
Registered
2011-12-05
Start date
2009-08-13
Completion date
2014-01-31
Last updated
2019-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infection

Keywords

severe bacterial infection

Brief summary

The aim of the study is to determine the frequency of sub-optimal care in the initial care (before arrival at the intensive care unit) of children from West France regions suffering of severe bacterial infections.The characteristic optimal or not of the initial medical care will be determined by 2 independent experts, blinded from each other and blinded from the issue of the care. In case of a discordance between the two experts, a third expert will be demanded. Three possibilities of conclusion will be proposed to the experts: sure sub-optimal medical care, possible suboptimal care and optimal care.

Interventions

OTHERRetrospective examination by experts whether care given fo child admitted at the ICU for suspicion of bacterial infection (not nosocomial) was optimal or not

When child is admitted at Intensive Care Unit (ICU) for suspicion of bacterial infection that is not nosocomial, data on child's infection and cares received, is completed on an electronic Case Report Form (e-CRF) by Doctor of ICU. Characteristic optimal or not of initial medical care is then determined by the independent experts blinded from issue of the care.

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 16 Years
Healthy volunteers
No

Inclusion criteria

* Child from West France regions * Aged between 1 month and 16 years old, * Admitted at the intensive care unit for a severe bacterial infection and with the first symptoms appeared when child was at home or hospitalized since less than 48h * Children dead at home will also be included in this study via the mobil medical urgency help unit (french term : SAMU)

Exclusion criteria

* Patient not fulfilling inclusion criteria * Child with a nosocomial infection * Child dead or admitted at the intensive care unit following a pertussis- Child not admitted at the intensive care or not dead at home in a context of infection. * Child with viral or fungic infection admitted at the intensive care unit.

Design outcomes

Primary

MeasureTime frameDescription
Frequency of optimal care and of non optimal care in the initial care (before arrival at the intensive care unit) of children (from West France regions) suffering of severe bacterial infections.1dayFor each child medical file, the verdict optimal care or the verdict non optimal care will be determined by two independent experts, blinded from each other. If verdict base their judgement through recommendations listed in the literature.

Secondary

MeasureTime frameDescription
characteristics of sub-optimal cares1 dayExperts will explain their verdict by answering to a list of questions. These questions will allow to identify and classify characteristics of defaults of cares .
determinants of sub-optimal cares1 dayTo identify determinants of sub-optimal cares (examples : place of medical care, qualification and experience of the Medical Doctor, moment of medical care.
consequences of initial sub-optimal cares1 dayTo identify consequences of initial sub-optimal cares on the outcome of children with severe bacterial infections (child death, etc).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026