Trials / Completed
CompletedNCT03602209
Short vs. Long Antibiotic Treatment of Implant-free Osteoarticular Infections
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- University Hospital, Geneva · Academic / Other
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Removal of infected implant | |
| DRUG | Antibiotic durations |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2018-02-28
- Completion
- 2018-05-18
- First posted
- 2018-07-26
- Last updated
- 2018-08-01
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT03602209. Inclusion in this directory is not an endorsement.