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Retrospective Examination of Initial Care of Severe Bacterial Infections of the Child (Diabact)

Primary Purpose

Bacterial Infection

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Retrospective examination by experts whether care given fo child admitted at the ICU for suspicion of bacterial infection (not nosocomial) was optimal or not
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Bacterial Infection focused on measuring severe bacterial infection

Eligibility Criteria

1 Month - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU of Nantes

Outcomes

Primary Outcome Measures

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.
For 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 Outcome Measures

characteristics of sub-optimal cares
Experts 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 cares
To 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 cares
To identify consequences of initial sub-optimal cares on the outcome of children with severe bacterial infections (child death, etc).

Full Information

First Posted
September 6, 2011
Last Updated
September 13, 2019
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01485705
Brief Title
Retrospective Examination of Initial Care of Severe Bacterial Infections of the Child
Acronym
Diabact
Official Title
Frequency, Consequences and Determinants of Sub-optimal Care in the Initial Care of Severe Bacterial Infections of the Child
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 13, 2009 (Actual)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infection
Keywords
severe bacterial infection

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
371 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Retrospective examination by experts whether care given fo child admitted at the ICU for suspicion of bacterial infection (not nosocomial) was optimal or not
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
For 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.
Time Frame
1day
Secondary Outcome Measure Information:
Title
characteristics of sub-optimal cares
Description
Experts will explain their verdict by answering to a list of questions. These questions will allow to identify and classify characteristics of defaults of cares .
Time Frame
1 day
Title
determinants of sub-optimal cares
Description
To identify determinants of sub-optimal cares (examples : place of medical care, qualification and experience of the Medical Doctor, moment of medical care.
Time Frame
1 day
Title
consequences of initial sub-optimal cares
Description
To identify consequences of initial sub-optimal cares on the outcome of children with severe bacterial infections (child death, etc).
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
CHU of Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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