Dosing of Antibiotics During Reimplantation of Infected Knee and Hip Prostheses
DOSOS
Dosing of Antibiotics (Serum and Periprosthetic Tissues) During Reimplantation of Infected Knee and Hip Prostheses
1 other identifier
observational
30
1 country
5
Brief Summary
The purpose of the study is to evaluate the concentrations of antibiotics used as empirical treatment in serum and periprosthetic tissues during reimplantation of infected hip and knee prostheses
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2016
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 5, 2016
CompletedFirst Posted
Study publicly available on registry
August 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 3, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 3, 2017
CompletedOctober 11, 2017
August 1, 2016
1.2 years
August 5, 2016
October 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary outcome measure was the evaluation of concentrations in serum and periprosthetic tissues of antibiotic agents used as empirical therapy during reimplantation of the infected prosthesis
1 day
Secondary Outcomes (1)
Secondary outcome will analyze the ratio of antibiotic concentration in serum and prosthetic tissues to minimum inhibitory concentration of the concerned antibiotic for the pathogen(s) identified in intraoperative samples
1 day
Eligibility Criteria
Adult patients with hip and knee prostheses infections
You may qualify if:
- Adult patients (aged of 18 years or more) who undergo reimplantation surgery for infected hip or knee prosthesis (performed in 1 or 2-stage(s)), and for whom referral physicians plans to use an empirical antibiotic therapy including cefotaxime, ceftriaxone, cefepime, daptomycin, or vancomycin.
You may not qualify if:
- Patients with multiple prosthetic joint infections, or with curative antibiotic therapy ongoing within two weeks or less prior to surgery, or for whom an antibiotic prophylaxis is decided by referral for the reimplantation surgery, or for whom an antibiotic-loaded cement containing the same antibiotic chosen for empirical therapy after reimplantation was used in case of 2-stage exchange
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
CHU
Amiens, 80054, France
CHU
Caen, 14033, France
CHRU
Lille, 59037, France
CHU
Rouen, 76031, France
Dron Hospital
Tourcoing, 59208, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eric M Senneville, MD, PhD
Dron Hospital Tourcoing France
- PRINCIPAL INVESTIGATOR
Sophie Nguyen, MD
Dron Hospital Tourcoing France
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2016
First Posted
August 9, 2016
Study Start
August 1, 2016
Primary Completion
October 3, 2017
Study Completion
October 3, 2017
Last Updated
October 11, 2017
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share