Cost of Off-label Antibiotics in Osteoarticular Infections
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|ClinicalTrials.gov Identifier: NCT03335592|
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : May 6, 2020
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)
|Condition or disease|
|Bone Infection Joint Infection|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|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|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||April 1, 2021|
|Estimated Study Completion Date :||April 1, 2022|
- Estimation of the cost of the off-label antibiotics [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335592
|Contact: Tristan FERRY, MD, PhD||0472071107 ext +email@example.com|
|Contact: Eugénie MABRUT||0426732938 ext +firstname.lastname@example.org|
|Centre de Référence des Infections Ostéo-Articulaires complexes (CRIOAc Lyon)||Recruiting|
|Lyon, France, 69004|
|Contact: Tristan FERRY|