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We implement a prospective, randomized, unblinded, non-inferiority trial regarding the duration of systemic, targeted antibiotic therapy after the first surgical debridement for spine infection; randomizing 1:1 between
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| short antibiotic therapy | Experimental | 3 weeks of antibiotic therapy with no implant left in place 6 weeks of antibiotic therapy with implant left in place |
|
| long antibiotic therapy | Active Comparator | 6 weeks of antibiotic therapy with no implant in place 12 weeks of antibiotic therapy with implant left in place |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| duration of standard antibiotic therapy | Drug | antibiotic therapy for spine infections. 3 vs 6 weeks if no implant left in place. 6 vs 12 weeks if implant left in place. The antibiotic agents used are officially indicated for orthopedic infections, including spine infections and available in Switzerland since decades. Standard dosing will be applied and only modified according to the patient's co-morbidities, intolerances and weight. |
| Measure | Description | Time Frame |
|---|---|---|
| Remission of infection at 12 months after treatment | no clinical and microbiological recurrences | 12 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| costs | total costs for treatment of infection | up to 12 months |
| duration of sick leave | duration of sick leave for treatment of infection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ilker Uckay, PD Dr med | Contact | +41 44 386 1111 | ilker.uckay@balgrist.ch | |
| Michael Betz, PD Dr med | Contact | +41 44 386 1111 | michael.betz@balgrist.ch |
| Name | Affiliation | Role |
|---|---|---|
| Ilker Uckay, PD Dr med | Balgrist University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Balgrist University Hospital | Recruiting | Zurich | Canton of Zurich | 8008 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41464652 | Derived | Zendeli 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. | |
| 32028985 | Derived |
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identifying IPD will not be shared with other Researchers
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 24, 2022 | Jul 1, 2022 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D047090 | beta-Lactams |
| D007769 | Lactams |
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1:1 randomization
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|
|
| up to 12 months |
| length of hospital stay | number of days of hospital stay | up to 12 months |
| Betz 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. |
| D000577 |
| Amides |
| D009930 | Organic Chemicals |
| D000658 | Amoxicillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |