NCT01485705

Brief 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".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
371

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 13, 2009

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 5, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

4.4 years

First QC Date

September 6, 2011

Last Update Submit

September 13, 2019

Conditions

Bacterial Infection

Keywords

severe bacterial infection

Outcome Measures

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.

    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 Outcomes (3)

  • characteristics of sub-optimal cares

    1 day

  • determinants of sub-optimal cares

    1 day

  • consequences of initial sub-optimal cares

    1 day

Interventions

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

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 Criteria

Age1 Month - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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")

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU of Nantes

Nantes, 44093, France

Location

Related Publications (1)

  • 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.

    PMID: 37260312DERIVED

MeSH Terms

Conditions

Bacterial Infections

Interventions

Nuclear Receptor Subfamily 4, Group A, Member 2

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Orphan Nuclear ReceptorsDNA-Binding ProteinsProteinsAmino Acids, Peptides, and ProteinsReceptors, Cytoplasmic and Nuclear

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2011

First Posted

December 5, 2011

Study Start

August 13, 2009

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

September 17, 2019

Record last verified: 2019-09

Locations

FR(1)