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Short vs. Long Antibiotic Treatment of Implant-free Osteoarticular Infections

University Hospitals (UH) logo

University Hospitals (UH)

Status

Completed

Conditions

Implant Infection

Treatments

Procedure: Removal of infected implant
Drug: Antibiotic durations

Study type

Interventional

Funder types

Other

Identifiers

NCT03602209
No. 14-198

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

4 weeks of treatment
Experimental group
Treatment:
Procedure: Removal of infected implant
Drug: Antibiotic durations
6 weeks of treatment
Active Comparator group
Treatment:
Procedure: Removal of infected implant
Drug: Antibiotic durations

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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