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

This study is currently recruiting participants.
Verified September 2012 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01485705
First received: September 6, 2011
Last updated: December 7, 2012
Last verified: September 2012
History of Changes

September 6, 2011
December 7, 2012
August 2009
August 2013   (final data collection date for primary outcome measure)
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. [ Time Frame: 1day ] [ Designated as safety issue: Yes ]
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.
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. [ Time Frame: 1day ] [ Designated as safety issue: Yes ]
For each child medical file, the verdict "optimal care" or the verdict " non optimal care" will be determined by two independant experts, blinded from each other. If verdict base their judgement through recommandations listed in the litterature.
Complete list of historical versions of study NCT01485705 on ClinicalTrials.gov Archive Site
  • characteristics of sub-optimal cares [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    To identify consequences of initial sub-optimal cares on the outcome of children with severe bacterial infections (child death, etc).
Same as current
Not Provided
Not Provided
 
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

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".
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Bacterial Infection
Other: Retrospective 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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
270
Not Provided
August 2013   (final data collection date for primary outcome measure)

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.
Both
1 Month to 16 Years
No
Contact: Christèle GRAS-LE GUEN, Doctor +33 2 40 08 76 71 christele.grasleguen@chu-nantes.fr
France
 
NCT01485705
BRD 08/6-T
No
Nantes University Hospital
Nantes University Hospital
Not Provided
Not Provided
Nantes University Hospital
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP