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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03335592

Enrollment

1000

Registered

2017-11-07

Start date

2017-01-01

Completion date

2022-04-01

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Infection, Joint Infection

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)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

France

Outcome results