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

September 13, 2019 updated by: Nantes University Hospital

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".

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

371

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44093
        • CHU of Nantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
1day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
characteristics of sub-optimal cares
Time Frame: 1 day
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 .
1 day
determinants of sub-optimal cares
Time Frame: 1 day
To identify determinants of sub-optimal cares (examples : place of medical care, qualification and experience of the Medical Doctor, moment of medical care.
1 day
consequences of initial sub-optimal cares
Time Frame: 1 day
To identify consequences of initial sub-optimal cares on the outcome of children with severe bacterial infections (child death, etc).
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2009

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

September 6, 2011

First Submitted That Met QC Criteria

December 1, 2011

First Posted (Estimate)

December 5, 2011

Study Record Updates

Last Update Posted (Actual)

September 17, 2019

Last Update Submitted That Met QC Criteria

September 13, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRD/08/06-T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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