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

NCT ID: NCT01485705

Last Updated: 2019-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

371 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-13

Study Completion Date

2014-01-31

Brief Summary

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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".

Detailed Description

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Conditions

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Bacterial Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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")

* 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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU of Nantes

Nantes, , France

Site Status

Countries

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France

References

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Malorey D, Lorton F, Chalumeau M, Bourgoin P, Boussicault G, Chantreuil J, Gaillot T, Roue JM, Martinot A, Assathiany R, Saulnier JP, Caillon J, Grain A, Gras-Le Guen C, Launay E. Distribution, Consequences, and Determinants of Time to Antibiotics in Children With Community-Onset Severe Bacterial Infection: A Secondary Analysis of a Prospective Population-Based Study. Pediatr Crit Care Med. 2023 Sep 1;24(9):e441-e451. doi: 10.1097/PCC.0000000000003306. Epub 2023 Jun 1.

Reference Type DERIVED
PMID: 37260312 (View on PubMed)

Other Identifiers

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BRD/08/06-T

Identifier Type: -

Identifier Source: org_study_id

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