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

Bacterial Infection Clinical Trial

— Diabact  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01485705
• Other study ID #: BRD/08/06-T
• Status: Completed
• Phase: N/A
• Start date: August 13, 2009
• Est. completion date: January 2014

Study information

• Verified date: September 2019
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 371
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infection
• Bacterial Infections
• Communicable Diseases
• Infection

Intervention

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.

Locations

Country	Name	City	State
France	CHU of Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	characteristics of sub-optimal cares	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
Secondary	determinants of sub-optimal cares	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
Secondary	consequences of initial sub-optimal cares	To identify consequences of initial sub-optimal cares on the outcome of children with severe bacterial infections (child death, etc).	1 day