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Completed

NCT Number: NCT05499481

Short Against Long Antibiotic Therapy for Infected Orthopedic Sites

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.

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Key information

Conditions

Orthopedic Devices Associated With Misadventures Antibiotic Side Effect Infection, Surgical Site Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Balgrist University Hospital

Zurich, 8008, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibiotic

Drug

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.

Primary outcomes

  1. Clinical remission related to the duration of total, postdebridement, antibiotic use

    Time frame: 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery

    Clinical assessment during routine surgical controls. Definition of clinical failure accoding to to sandard criteria in the literature (surgical revision, pain, local inflammation, discharge, several deep intraoperative bacterial tissue samples)

  2. Microbiological recurrence in relation to the total, postdebridement, antibiotic use

    Time frame: 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery

    Recurrence of infection, with the same pathogens, after completing the antibiotic treatment for the index infection

Secondary outcomes

  1. Description of all clinical failures of any sort

    Time frame: 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery

    Need for hospitalisation or revision surgery for any non-infectious failures related to the operation wound (hematoma, seroma, internal (closed) fractures, dislocation of implants)

  2. Adverse events in each study arm, and in relation to the antibiotics used

    Time frame: 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery

    All adverse events during the therapy and follow-up time , with an emphasis on antibiotic-related adverse events (according to medical judgement). Numbers and descriptions.

  3. Length of hospital stay in acute care surgery (without rehabilitation)

    Time frame: 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery

    The duration of the hospital stay for every episode in both randomizing arm

Sponsors and collaborators

Lead sponsor

Balgrist University Hospital

Other

Registry information

Acronym: SALATIO

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2022
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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