Clinical trial NCT03602209: 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
Overall status: COMPLETED
Phase: NA
Conditions: Implant Infection
Keywords: implant-related infections
orthopaedics
implant removal
antibiotic duration
outcome
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Remission of infection
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
affiliation: University Hospital, Geneva
name: Ilker Uçkay, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.