Short Against Long Antibiotic Therapy for Infected Orthopedic Sites

• Status: Not yet recruiting
• Trial end date: 2025-09-30
• Target enrollment: 0
• Participant gender: All

Summary

We 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Balgrist University Hospital
• Treatments: Anti-Bacterial Agents

Criteria

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