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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01485705
First received: September 6, 2011
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

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".


Condition Intervention
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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Frequency, Consequences and Determinants of Sub-optimal Care in the Initial Care of Severe Bacterial Infections of the Child

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

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. [ 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.


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 270
Study Start Date: August 2009
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   1 Month to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485705

Locations
France
CHU of Nantes
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01485705     History of Changes
Other Study ID Numbers: BRD 08/6-T
Study First Received: September 6, 2011
Last Updated: July 1, 2014
Health Authority: France : committee of the protection of personnes

Keywords provided by Nantes University Hospital:
severe bacterial infection

Additional relevant MeSH terms:
Bacterial Infections
Communicable Diseases
Infection

ClinicalTrials.gov processed this record on October 20, 2014