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Cost of Off-label Antibiotics in Osteoarticular Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335592
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Eugénie MABRUT, 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)


Condition or disease
Bone Infection Joint Infection

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics




Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335592


Contacts
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Contact: Tristan FERRY, MD, PhD 0472071107 ext +33 tristan.ferry@chu-lyon.fr
Contact: Eugénie MABRUT 0426732938 ext +33 eugenie.mabrut@chu-lyon.fr

Locations
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France
Centre de Référence des Infections Ostéo-Articulaires complexes (CRIOAc Lyon) Recruiting
Lyon, France, 69004
Contact: Tristan FERRY         
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Eugénie MABRUT, Clinical Research Assistant, Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03335592    
Other Study ID Numbers: 17-203
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases