Short Against Long Antibiotic Therapy for Infected Orthopedic Sites (SALATIO)

Balgrist University Hospital

Status and phase: Completed; Phase 3

Conditions: Antibiotic Side Effect; Orthopedic Devices Associated With Misadventures; Infection, Surgical Site

Treatments: Drug: Antibiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT05499481

BASEC 2022-01012

Details and patient eligibility

About

The investigators will perform two concomitant RCTs, depending on the presence of infected osteosynthesis material at enrolment:

• SALATIO 1. Infected implant not removed (or new material inserted): Randomization 6 vs. 12 weeks (+/- 5 days) of total antibiotic therapy counted since the first debridement for infection. Early switch to oral targeted therapy.

• SALATIO 2. Infected implant without residual material (definitive removal or within the interval of a two-stage exchange): Randomization 3 vs. 6 weeks (+/- 5 days) of total antibiotic therapy counted since the first debridement for infection. Early switch to oral targeted therapy.

Full description

The optimal duration of postoperative, systemic antibiotic therapy for implant-related orthopedic infections, with or without implant removal, is unknown.

Retrospective studies suggest that a maximum duration of 6 weeks is not inferior to longer administrations; even if the infected implants are kept in place or during a one-stage exchange. Prospective-randomized trials (RCT) suggest that even shorter durations, such 3 or 4 weeks, are possible, when the implant is removed. Likewise, in prospective studies, 6 or 8 weeks of systemic antibiotics are not inferior to the current 12 weeks during DAIR (debridement, antibiotic and implant retention), or during the one-stage exchange; except for one single RCT suggesting a better outcome for 12 weeks in the substrata of arthroplasty infections undergoing the DAIR procedure.

However, these RCTs concern selected branches of orthopedic surgery; especially prosthetic joint infections. The investigators intend to expand these evaluations to all fields of orthopedic and hand surgery. The only exceptions would be spine surgery, for which a multicenter, separate RCT is already under way (SASI-trials). The second exception would be the treatment of implant-free diabetic foot infections, for which two RCTs are underway.

Enrollment: 495 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years on admission
• Orthopedic bone and implant infections including musculoskeletal grafts
• Intraoperative debridement with any surgical technique
• 12 months of scheduled follow-up from hospitalization
• Bacterial orthopedic infections of any nature
• First or second episode of infection

Exclusion criteria

• Mycobacterial, fungal, nocardial, and Actinomyces infections
• Purely soft tissue infections
• Non-resected cancer in the infection site
• Purely intrasynovial infections (native joint septic arthritis)
• More than three debridements performed for infection
• Absence of at least one surgical intraoperative debridement
• Spine infections (investigated in another trial)10
• Diabetic foot infections (investigated in another trial)7
• Documented endocarditis according to the Duke criteria
• At least 2 prior infection episodes at the actual infection site

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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495 participants in 2 patient groups

Long Antibiotic Arm

Active Comparator group

Description:

Without implant material in place: 6 weeks of systemic post-surgical antibiotic therapy With mateial in place 12 weeks of systemic post-surgical antibiotic therapy

Treatment:

Drug: Antibiotic

Short Antibiotic Arm

Experimental group

Description:

Without implant material in place: 3 weeks of systemic post-surgical antibiotic therapy With mateial in place 6 weeks of systemic post-surgical antibiotic therapy

Treatment:

Drug: Antibiotic