Orthopedic Devices Associated With MisadventuresPhase 3SALATIONCT05499481
Short Against Long Antibiotic Therapy for Infected Orthopedic Sites
A Phase 3 study testing Antibiotic in people with Orthopedic Devices Associated With Misadventures and Infection, Surgical Site, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Devices Associated With Misadventures, Infection, Surgical Site, Antibiotic Side Effect
- What is being tested?
- Antibiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 495 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Sep 2022to 30 Jun 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Orthopedic Devices Associated With Misadventures, Infection, Surgical Site, Antibiotic Side Effect
- Being tested
- Antibiotic
- Keywords
- Orthopedic infectionsT, Duration, Antibiotic Therapy, Randomized-Controlled Trial
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Long Antibiotic Arm | Active comparator | 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 Receives: Drug: Antibiotic |
| Short Antibiotic Arm | Experimental | 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 Receives: Drug: Antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission related to the duration of total, postdebridement, antibiotic use
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)
Measured: 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery
Microbiological recurrence in relation to the total, postdebridement, antibiotic use
Recurrence of infection, with the same pathogens, after completing the antibiotic treatment for the index infection
Measured: 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery
Secondary outcomes (3)
Description of all clinical failures of any sort
Need for hospitalisation or revision surgery for any non-infectious failures related to the operation wound (hematoma, seroma, internal (closed) fractures, dislocation of implants)
Measured: 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery
Adverse events in each study arm, and in relation to the antibiotics used
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.
Measured: 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery
Length of hospital stay in acute care surgery (without rehabilitation)
The duration of the hospital stay for every episode in both randomizing arm
Measured: 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start15 Sep 2022
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Orthopedic Devices Associated With MisadventuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model 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.
- Masking
- None (open label)
- Enrolment
- 495 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ilker Uçkay, Professor, Principal investigator, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499481
- Sponsor's protocol ID
- BASEC 2022-01012
- Acronym
- SALATIO
- Status last verified
- Jun 2025
- First submitted
- 11 Aug 2022
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators might share anonymized key elements upon reasonable scientific request to the corresponding persons
Publications
Chaussade H, Uckay I, Vuagnat A, Druon J, Gras G, Rosset P, Lipsky BA, Bernard L. Antibiotic therapy duration for prosthetic joint infections treated by Debridement and Implant Retention (DAIR): Similar long-term remission for 6 weeks as compared to 12 weeks. Int J Infect Dis. 2017 Oct;63:37-42. doi: 10.1016/j.ijid.2017.08.002. Epub 2017 Aug 10.
PubMed 28804007Bernard L, Legout L, Zurcher-Pfund L, Stern R, Rohner P, Peter R, Assal M, Lew D, Hoffmeyer P, Uckay I. Six weeks of antibiotic treatment is sufficient following surgery for septic arthroplasty. J Infect. 2010 Jul;61(2):125-32. doi: 10.1016/j.jinf.2010.05.005. Epub 2010 Jun 9.
PubMed 20540962Hirsiger S, Betz M, Stafylakis D, Gotschi T, Lew D, Uckay I. The Benefice of Mobile Parts' Exchange in the Management of Infected Total Joint Arthroplasties with Prosthesis Retention (DAIR Procedure). J Clin Med. 2019 Feb 9;8(2):226. doi: 10.3390/jcm8020226.
PubMed 30744128Farhad R, Roger PM, Albert C, Pelligri C, Touati C, Dellamonica P, Trojani C, Boileau P. Six weeks antibiotic therapy for all bone infections: results of a cohort study. Eur J Clin Microbiol Infect Dis. 2010 Feb;29(2):217-22. doi: 10.1007/s10096-009-0842-1. Epub 2009 Dec 10.
PubMed 20012334Gariani K, Pham TT, Kressmann B, Jornayvaz FR, Gastaldi G, Stafylakis D, Philippe J, Lipsky BA, Uckay L. Three Weeks Versus Six Weeks of Antibiotic Therapy for Diabetic Foot Osteomyelitis: A Prospective, Randomized, Noninferiority Pilot Trial. Clin Infect Dis. 2021 Oct 5;73(7):e1539-e1545. doi: 10.1093/cid/ciaa1758.
PubMed 33242083Waibel F, Berli M, Catanzaro S, Sairanen K, Schoni M, Boni T, Burkhard J, Holy D, Huber T, Bertram M, Laubli K, Frustaci D, Rosskopf A, Botter S, Uckay I. Optimization of the antibiotic management of diabetic foot infections: protocol for two randomized controlled trials. Trials. 2020 Jan 8;21(1):54. doi: 10.1186/s13063-019-4006-z.
PubMed 31915048Benkabouche M, Racloz G, Spechbach H, Lipsky BA, Gaspoz JM, Uckay I. Four versus six weeks of antibiotic therapy for osteoarticular infections after implant removal: a randomized trial. J Antimicrob Chemother. 2019 Aug 1;74(8):2394-2399. doi: 10.1093/jac/dkz202.
PubMed 31106353Rod-Fleury T, Dunkel N, Assal M, Rohner P, Tahintzi P, Bernard L, Hoffmeyer P, Lew D, Uckay I. Duration of post-surgical antibiotic therapy for adult chronic osteomyelitis: a single-centre experience. Int Orthop. 2011 Nov;35(11):1725-31. doi: 10.1007/s00264-011-1221-y. Epub 2011 Feb 12.
PubMed 21318568Betz M, Uckay I, Schupbach R, Grober T, Botter SM, Burkhard J, Holy D, Achermann Y, Farshad M. Short postsurgical antibiotic therapy for spinal infections: protocol of prospective, randomized, unblinded, noninferiority trials (SASI trials). Trials. 2020 Feb 6;21(1):144. doi: 10.1186/s13063-020-4047-3.
PubMed 32028985Argenson JN, Arndt M, Babis G, Battenberg A, Budhiparama N, Catani F, Chen F, de Beaubien B, Ebied A, Esposito S, Ferry C, Flores H, Giorgini A, Hansen E, Hernugrahanto KD, Hyonmin C, Kim TK, Koh IJ, Komnos G, Lausmann C, Loloi J, Lora-Tamayo J, Lumban-Gaol I, Mahyudin F, Mancheno-Losa M, Marculescu C, Marei S, Martin KE, Meshram P, Paprosky WG, Poultsides L, Saxena A, Schwechter E, Shah J, Shohat N, Sierra RJ, Soriano A, Stefansdottir A, Suleiman LI, Taylor A, Triantafyllopoulos GK, Utomo DN, Warren D, Whiteside L, Wouthuyzen-Bakker M, Yombi J, Zmistowski B. Hip and Knee Section, Treatment, Debridement and Retention of Implant: Proceedings of International Consensus on Orthopedic Infections. J Arthroplasty. 2019 Feb;34(2S):S399-S419. doi: 10.1016/j.arth.2018.09.025. Epub 2018 Oct 19. No abstract available.
PubMed 30348550Lora-Tamayo J, Euba G, Cobo J, Horcajada JP, Soriano A, Sandoval E, Pigrau C, Benito N, Falgueras L, Palomino J, Del Toro MD, Jover-Saenz A, Iribarren JA, Sanchez-Somolinos M, Ramos A, Fernandez-Sampedro M, Riera M, Baraia-Etxaburu JM, Ariza J; Prosthetic Joint Infection Group of the Spanish Network for Research in Infectious Diseases-REIPI. Short- versus long-duration levofloxacin plus rifampicin for acute staphylococcal prosthetic joint infection managed with implant retention: a randomised clinical trial. Int J Antimicrob Agents. 2016 Sep;48(3):310-6. doi: 10.1016/j.ijantimicag.2016.05.021. Epub 2016 Aug 3.
PubMed 27524103Bernard L, Arvieux C, Brunschweiler B, Touchais S, Ansart S, Bru JP, Oziol E, Boeri C, Gras G, Druon J, Rosset P, Senneville E, Bentayeb H, Bouhour D, Le Moal G, Michon J, Aumaitre H, Forestier E, Laffosse JM, Begue T, Chirouze C, Dauchy FA, Devaud E, Martha B, Burgot D, Boutoille D, Stindel E, Dinh A, Bemer P, Giraudeau B, Issartel B, Caille A. Antibiotic Therapy for 6 or 12 Weeks for Prosthetic Joint Infection. N Engl J Med. 2021 May 27;384(21):1991-2001. doi: 10.1056/NEJMoa2020198.
PubMed 34042388Keene S, Zendeli F, Schmid M, Kuhne N, Furrer PR, Uckay I. Short Against Long Antibiotic Therapy for Infected Orthopaedic Sites-2nd Interim Analysis of the SALATIO Trials. J Clin Med. 2026 Feb 24;15(5):1695. doi: 10.3390/jcm15051695.
PubMed 41827121Zendeli F, Jedrusik A, Schaefer RO, Albrecht D, Betz M, Waibel FWA, Grober T, Kuhne N, Konneker S, Uckay I. Pathogen-Specific Risk for Iterative Surgical Debridement in Orthopedic Infections: A Prospective Multicohort Analysis. J Clin Med. 2025 Dec 10;14(24):8750. doi: 10.3390/jcm14248750.
PubMed 41464652Uckay I, Wirth S, Zorner B, Fucentese S, Wieser K, Schweizer A, Muller D, Zingg P, Farshad M. Study protocol: short against long antibiotic therapy for infected orthopedic sites - the randomized-controlled SALATIO trials. Trials. 2023 Feb 18;24(1):117. doi: 10.1186/s13063-023-07141-2.
PubMed 36803837
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Against Long Antibiotic Therapy for Infected Orthopedic Sites
- ClinicalTrials.gov ID
- NCT05499481
- Acronym / sponsor ID
- SALATIO / BASEC 2022-01012
- Conditions
- Orthopedic Devices Associated With Misadventures, Infection, Surgical Site, Antibiotic Side Effect
- Keywords
- Orthopedic infectionsT, Duration, Antibiotic Therapy, Randomized-Controlled Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 495 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model 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.
| Arm | Type | Receives |
|---|---|---|
| Long Antibiotic Arm | Active comparator | Drug: AntibioticWithout implant material in place: 6 weeks of systemic post-surgical antibiotic therapy With mateial in place 12 weeks of systemic post-surgical antibiotic therapy |
| Short Antibiotic Arm | Experimental | Drug: AntibioticWithout implant material in place: 3 weeks of systemic post-surgical antibiotic therapy With mateial in place 6 weeks of systemic post-surgical antibiotic therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntibioticThe 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. | Drug | Long Antibiotic Arm, Short Antibiotic Arm |
Primary outcome
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)
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
3 secondary outcomes
Description of all clinical failures of any sort
Time frame: 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Background: PubMed 28804007Chaussade H, Uckay I, Vuagnat A, Druon J, Gras G, Rosset P, Lipsky BA, Bernard L. Antibiotic therapy duration for prosthetic joint infections treated by Debridement and Implant Retention (DAIR): Similar long-term remission for 6 weeks as compared to 12 weeks. Int J Infect Dis. 2017 Oct;63:37-42. doi: 10.1016/j.ijid.2017.08.002. Epub 2017 Aug 10.
- Background: PubMed 20540962Bernard L, Legout L, Zurcher-Pfund L, Stern R, Rohner P, Peter R, Assal M, Lew D, Hoffmeyer P, Uckay I. Six weeks of antibiotic treatment is sufficient following surgery for septic arthroplasty. J Infect. 2010 Jul;61(2):125-32. doi: 10.1016/j.jinf.2010.05.005. Epub 2010 Jun 9.
- Background: PubMed 30744128Hirsiger S, Betz M, Stafylakis D, Gotschi T, Lew D, Uckay I. The Benefice of Mobile Parts' Exchange in the Management of Infected Total Joint Arthroplasties with Prosthesis Retention (DAIR Procedure). J Clin Med. 2019 Feb 9;8(2):226. doi: 10.3390/jcm8020226.
- Background: PubMed 20012334Farhad R, Roger PM, Albert C, Pelligri C, Touati C, Dellamonica P, Trojani C, Boileau P. Six weeks antibiotic therapy for all bone infections: results of a cohort study. Eur J Clin Microbiol Infect Dis. 2010 Feb;29(2):217-22. doi: 10.1007/s10096-009-0842-1. Epub 2009 Dec 10.
- Background: PubMed 33242083Gariani K, Pham TT, Kressmann B, Jornayvaz FR, Gastaldi G, Stafylakis D, Philippe J, Lipsky BA, Uckay L. Three Weeks Versus Six Weeks of Antibiotic Therapy for Diabetic Foot Osteomyelitis: A Prospective, Randomized, Noninferiority Pilot Trial. Clin Infect Dis. 2021 Oct 5;73(7):e1539-e1545. doi: 10.1093/cid/ciaa1758.
- Background: PubMed 31915048Waibel F, Berli M, Catanzaro S, Sairanen K, Schoni M, Boni T, Burkhard J, Holy D, Huber T, Bertram M, Laubli K, Frustaci D, Rosskopf A, Botter S, Uckay I. Optimization of the antibiotic management of diabetic foot infections: protocol for two randomized controlled trials. Trials. 2020 Jan 8;21(1):54. doi: 10.1186/s13063-019-4006-z.
- Background: PubMed 31106353Benkabouche M, Racloz G, Spechbach H, Lipsky BA, Gaspoz JM, Uckay I. Four versus six weeks of antibiotic therapy for osteoarticular infections after implant removal: a randomized trial. J Antimicrob Chemother. 2019 Aug 1;74(8):2394-2399. doi: 10.1093/jac/dkz202.
- Background: PubMed 21318568Rod-Fleury T, Dunkel N, Assal M, Rohner P, Tahintzi P, Bernard L, Hoffmeyer P, Lew D, Uckay I. Duration of post-surgical antibiotic therapy for adult chronic osteomyelitis: a single-centre experience. Int Orthop. 2011 Nov;35(11):1725-31. doi: 10.1007/s00264-011-1221-y. Epub 2011 Feb 12.
- Background: PubMed 32028985Betz M, Uckay I, Schupbach R, Grober T, Botter SM, Burkhard J, Holy D, Achermann Y, Farshad M. Short postsurgical antibiotic therapy for spinal infections: protocol of prospective, randomized, unblinded, noninferiority trials (SASI trials). Trials. 2020 Feb 6;21(1):144. doi: 10.1186/s13063-020-4047-3.
- Background: PubMed 30348550Argenson JN, Arndt M, Babis G, Battenberg A, Budhiparama N, Catani F, Chen F, de Beaubien B, Ebied A, Esposito S, Ferry C, Flores H, Giorgini A, Hansen E, Hernugrahanto KD, Hyonmin C, Kim TK, Koh IJ, Komnos G, Lausmann C, Loloi J, Lora-Tamayo J, Lumban-Gaol I, Mahyudin F, Mancheno-Losa M, Marculescu C, Marei S, Martin KE, Meshram P, Paprosky WG, Poultsides L, Saxena A, Schwechter E, Shah J, Shohat N, Sierra RJ, Soriano A, Stefansdottir A, Suleiman LI, Taylor A, Triantafyllopoulos GK, Utomo DN, Warren D, Whiteside L, Wouthuyzen-Bakker M, Yombi J, Zmistowski B. Hip and Knee Section, Treatment, Debridement and Retention of Implant: Proceedings of International Consensus on Orthopedic Infections. J Arthroplasty. 2019 Feb;34(2S):S399-S419. doi: 10.1016/j.arth.2018.09.025. Epub 2018 Oct 19. No abstract available.
- Background: PubMed 27524103Lora-Tamayo J, Euba G, Cobo J, Horcajada JP, Soriano A, Sandoval E, Pigrau C, Benito N, Falgueras L, Palomino J, Del Toro MD, Jover-Saenz A, Iribarren JA, Sanchez-Somolinos M, Ramos A, Fernandez-Sampedro M, Riera M, Baraia-Etxaburu JM, Ariza J; Prosthetic Joint Infection Group of the Spanish Network for Research in Infectious Diseases-REIPI. Short- versus long-duration levofloxacin plus rifampicin for acute staphylococcal prosthetic joint infection managed with implant retention: a randomised clinical trial. Int J Antimicrob Agents. 2016 Sep;48(3):310-6. doi: 10.1016/j.ijantimicag.2016.05.021. Epub 2016 Aug 3.
- Background: PubMed 34042388Bernard L, Arvieux C, Brunschweiler B, Touchais S, Ansart S, Bru JP, Oziol E, Boeri C, Gras G, Druon J, Rosset P, Senneville E, Bentayeb H, Bouhour D, Le Moal G, Michon J, Aumaitre H, Forestier E, Laffosse JM, Begue T, Chirouze C, Dauchy FA, Devaud E, Martha B, Burgot D, Boutoille D, Stindel E, Dinh A, Bemer P, Giraudeau B, Issartel B, Caille A. Antibiotic Therapy for 6 or 12 Weeks for Prosthetic Joint Infection. N Engl J Med. 2021 May 27;384(21):1991-2001. doi: 10.1056/NEJMoa2020198.
- Individual participant dataSharing planned: Yes. The investigators might share anonymized key elements upon reasonable scientific request to the corresponding persons
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilker Uçkay, Professor principal investigator
Balgrist University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antibiotic in people with Orthopedic Devices Associated With Misadventures and Infection, Surgical Site, run by Balgrist University Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05499481, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.