Cost of Off-label Antibiotics in Osteoarticular Infections

Terminated

• Conditions: Bone Infection; Joint Infection

• Registration Number: NCT03335592
• Lead Sponsor: Hospices Civils de Lyon

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-11-03
• Study First Submitted QC: 2017-11-03
• Study First Posted: 2017-11-07
• Primary Completion: 2021-04-01
• Study Completion: 2022-04-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1000

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

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Exclusion Criteria

None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimation of the cost of the off-label antibiotics	50 days	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.

Trial Locations

Locations (1)

Centre de Référence des Infections Ostéo-Articulaires complexes (CRIOAc Lyon); 🇫🇷 Lyon, France