Back to resultsShort vs. Long Antibiotic Treatment of Implant-free Osteoarticular Infections
Primary Purpose
Implant Infection
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Removal of infected implant
Antibiotic durations
Sponsored by
About this trial
This is an interventional treatment trial for Implant Infection focused on measuring implant-related infections, orthopaedics, implant removal, antibiotic duration, outcome
Eligibility Criteria
Inclusion Criteria:
- Adult patients (≥17 years old)
- Total removal of the implant
Exclusion Criteria:
- Primary native joint septic arthritis;
- Co-trimoxazole prophylaxis because of immunosuppression;
- Left-side endocarditis;
- Persistent implant material in the infected area.
- Infections with tuberculosis; mycobacteria; fungi; brucellosis; borreliosis; nocardiosis; and mycoplasmal osteosynthesis infections
Sites / Locations
- Geneva University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
4 weeks of treatment
6 weeks of treatment
Arm Description
Outcomes
Primary Outcome Measures
Remission of infection
Clinical evaluation
Adverse events
Clinical adverse events
Secondary Outcome Measures
Full Information
NCT ID
NCT03602209
First Posted
January 17, 2017
Last Updated
July 30, 2018
Sponsor
University Hospital, Geneva
1. Study Identification
Unique Protocol Identification Number
NCT03602209
Brief Title
Short vs. Long Antibiotic Treatment of Implant-free Osteoarticular Infections
Official Title
Short vs. Long Antibiotic Treatment of Implant-free Osteoarticular Infections
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
May 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators tested the working hypothesis if 4 weeks of systemic antibiotic treatment in implant-related orthopaedic infections is non-inferior to 6 weeks after complete removal of the infected implant. Randomization 1:1.
The study is completed. It halted prematurely and will not resume; participants are no longer being examined or receiving intervention.
Detailed Description
Former description of the study (now completed)
Osteoarticular infections related to orthopaedic implants are associated with substantial morbidity, prolongation of hospital stay, and additional costs. Due to the increasing number of patients with orthopaedic implants in Switzerland, similar to the rest of Europe and elsewhere, the number of infections is expected to increase. While the surgical treatment of these infections has been well studied, the ideal duration of antibiotic therapy after removal (explantation) of the infected implant remains unknown. For almost 40 years, the recommended total duration of post-explantation antibiotic therapy has been 6 weeks. This recommendation is based on expert's personal experience rather than on prospective randomized studies. Shorter treatment would decrease antibiotic-related adverse events and costs hospital stay for patients awaiting an eventual reinsertion of a new implant. If physicians and surgeon prescribe antibiotics for 6 weeks, this duration should be at least supported by evidence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Implant Infection
Keywords
implant-related infections, orthopaedics, implant removal, antibiotic duration, outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
4 weeks of treatment
Arm Type
Experimental
Arm Title
6 weeks of treatment
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Removal of infected implant
Intervention Type
Drug
Intervention Name(s)
Antibiotic durations
Primary Outcome Measure Information:
Title
Remission of infection
Description
Clinical evaluation
Time Frame
12 months
Title
Adverse events
Description
Clinical adverse events
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients (≥17 years old)
Total removal of the implant
Exclusion Criteria:
Primary native joint septic arthritis;
Co-trimoxazole prophylaxis because of immunosuppression;
Left-side endocarditis;
Persistent implant material in the infected area.
Infections with tuberculosis; mycobacteria; fungi; brucellosis; borreliosis; nocardiosis; and mycoplasmal osteosynthesis infections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilker Uçkay, MD
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geneva University Hospitals
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24052163
Citation
Al-Mayahi M, Betz M, Muller DA, Stern R, Tahintzi P, Bernard L, Hoffmeyer P, Suva D, Uckay I. Remission rate of implant-related infections following revision surgery after fractures. Int Orthop. 2013 Nov;37(11):2253-8. doi: 10.1007/s00264-013-2092-1. Epub 2013 Sep 20.
Results Reference
background
Learn more about this trial
Short vs. Long Antibiotic Treatment of Implant-free Osteoarticular Infections
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