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NCT03335592 Clinical Trial

Cost of Off-label Antibiotics in Osteoarticular Infections

Joint Infection Clinical Trial

Official title:
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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03335592
Other study ID # 17-203
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date April 1, 2022

Study information
Verified date February 2024
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)

Recruitment information / eligibility
Status Terminated
Enrollment 1000
Est. completion date April 1, 2022
Est. primary completion date April 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Centre de Référence des Infections Ostéo-Articulaires complexes (CRIOAc Lyon) Lyon

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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