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Completed

NCT Number: NCT01485705

Retrospective Examination of 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".

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Key information

Conditions

Bacterial Infection Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

1 month–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU of Nantes

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. 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 .

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: Diabact

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Dec 5, 2011
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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