Cost of Off-label Antibiotics in Osteoarticular Infections

Cost of Off-label Antibiotics in Osteoarticular Infections: Prospective Study Over 2 Years in a Reference Center for the Management of Complex Bone and Joint Infection

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)

Study Overview

• Status: Terminated
• Conditions: Bone Infection; Joint Infection

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Centre de Référence des Infections Ostéo-Articulaires complexes (CRIOAc Lyon)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

- 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

Exclusion Criteria:

None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: November 3, 2017
• First Submitted That Met QC Criteria: November 3, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 17-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No