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NCT05499481: SALATIO

Short Against Long Antibiotic Therapy for Infected Orthopedic Sites

Completed Phase 3 Last updated 2 July 2025
What this trial tests

Phase 3 trial testing Antibiotic in Orthopedic Devices Associated With Misadventures in 495 participants. Completed in 30 June 2025.

Timeline
15 September 2022
Primary endpoint
30 June 2025
30 June 2025

Quick facts

Lead sponsorBalgrist University Hospital
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment495
Start date15 September 2022
Primary completion30 June 2025
Estimated completion30 June 2025
Sites1 location across Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

Balgrist University Hospital

Who can join

18 and older, any sex, with Orthopedic Devices Associated With Misadventures or Infection, Surgical Site. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Study protocol: short against long antibiotic therapy for infected orthopedic sites - the randomized-controlled SALATIO trials.
    Uçkay I, Wirth S, Zörner B, Fucentese S, et al · · 2023 · cited 4× · PMID 36803837 · DOI 10.1186/s13063-023-07141-2
  2. Pathogen-Specific Risk for Iterative Surgical Debridement in Orthopedic Infections: A Prospective Multicohort Analysis.
    Zendeli F, Jędrusik A, Schaefer RO, Albrecht D, et al · · 2025 · cited 1× · PMID 41464652 · DOI 10.3390/jcm14248750
  3. Short Against Long Antibiotic Therapy for Infected Orthopaedic Sites—2nd Interim Analysis of the SALATIO Trials
    Keene S, Zendeli F, Schmid M, Kühne N, et al · · 2026
  4. Short Against Long Antibiotic Therapy for Infected Orthopaedic Sites-2nd Interim Analysis of the SALATIO Trials.
    Keene S, Zendeli F, Schmid M, Kühne N, et al · · 2026 · PMID 41827121 · DOI 10.3390/jcm15051695
  5. Short Against Long Antibiotic Therapy for Infected Orthopaedic Sites - 2nd Interim Analysis of the SALATIO Trials
    Keene S, Zendeli F, Schmid M, Kühne N, et al · · 2026 · DOI 10.20944/preprints202601.0663.v1
  6. Pathogen-Specific Risk for Iterative Surgical Debridement in Orthopedic Infections: A Prospective Multicohort Analysis
    Zendeli F, Jedrusik A, Schäfer RO, Albrecht D, et al · · 2025 · DOI 10.20944/preprints202511.0784.v1
  7. Study Protocol: Short Against Long Antibiotic Therapy for Infected Orthopaedic Sites - SALATIO Trials
    Uçkay I, Wirth S, Zörner B, Fucentese S, et al · · 2022 · DOI 10.21203/rs.3.rs-2108540/v1

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