NCT03335592

Brief Summary

Due to the emergence of multidrug-resistant micro-organisms in patients with bone and joint infection (BJI), the prescription of off-labeled antibiotics seem to be more and more common as part of routine care. These new antibiotics are, however, more expensive, and there are no precise data in France regarding the volume and cost of such off-label prescriptions in hospital, in the post-acute care structures, and in the outpatient setting. The objective of this study is to estimate the cost of using these antibiotics over 2 years for patients in a reference center for the management of complex bone and joint infection (CRIOAc)

Trial Health

57
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Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

4.2 years

First QC Date

November 3, 2017

Last Update Submit

February 27, 2024

Conditions

Bone InfectionJoint Infection

Outcome Measures

Primary Outcomes (1)

  • Estimation of the cost of the off-label antibiotics

    The molecule concerned are: daptomycin, ertapenem, linezolid, ceftaroline, tigecycline and / or colimycin. The characteristics of the patients, the type of bone and joint infection and the prescribing methods (dosage, duration) were collected throughout the care path (hospitalization in surgery and / or medicine at CRIOAc or in peripheral hospitals, in post-acute care structure and in the home). The duration of dispensation is about 50 days. Overall costs for off-label prescriptions were estimated taking account of variations in purchase price invoiced to the reference center.

    50 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients having had off-label antibiotics to treat bone and/or joint infection, with or without implant

You may qualify if:

  • \- Patients having had off-label antibiotics between 2014 and 2015 to treat bone and/or joint infection, with or without implant and managed at the CRIOAc Lyon

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Référence des Infections Ostéo-Articulaires complexes (CRIOAc Lyon)

Lyon, 69004, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Assistant

Study Record Dates

First Submitted

November 3, 2017

First Posted

November 7, 2017

Study Start

January 1, 2017

Primary Completion

April 1, 2021

Study Completion

April 1, 2022

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)