NCT02842710

Brief Summary

The main objective of this study and to know the incidence of healthy carriers of Staphylococcus aureus resistant méti- patients supported for fracture of the proximal femur . This assessment will be made preoperatively by a nasal sampling and analysis through it by rapid Polymerase Chain Reaction method GeneXpert® .

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Status
withdrawn

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

June 4, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 25, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2018

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

2.5 years

First QC Date

July 20, 2016

Last Update Submit

November 9, 2020

Conditions

Emergencies

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Staphylococcus aureus resistant to methicillin nasal carriage in the population supported to trauma emergencies

    To evaluate the prevalence of Staphylococcus aureus resistant to methicillin nasal carriage in the population supported to trauma emergencies

    12 months

Study Arms (1)

GeneXpert®

EXPERIMENTAL

Detection is carried out after a sample within the patient's nasal cavity. The swab containing the sample is placed in the PLC GeneXpert® Cepheid . The analysis takes one hour . The results leave automatically.

Device: GeneXpert®

Interventions

GeneXpert®DEVICE

Detection is carried out after a sample within the patient's nasal cavity. The swab containing the sample is placed in the PLC GeneXpert® Cepheid . The analysis takes one hour . The results leave automatically.

GeneXpert®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient treated in the trauma unit for fractures of the proximal femur belong to a social security scheme patient

You may not qualify if:

  • Minor patient
  • Presence of abrasions
  • MRSA history
  • Open fracture
  • Ongoing infectious process
  • Patients under judicial protection , guardianship
  • Pregnant or breastfeeding women
  • patient refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nicolas Reina, Dr

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

July 20, 2016

First Posted

July 25, 2016

Study Start

June 4, 2016

Primary Completion

December 15, 2018

Study Completion

December 15, 2018

Last Updated

November 12, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share