InfectionNCT04048304
Short Post-surgical Antibiotic Therapy in Spine Infections - a Prospective, Randomized, Unblinded, Non-inferiority Trial
A study testing duration of standard antibiotic therapy in people with Infection, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
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 1. Six and twelve weeks of antibiotic therapy if there is an implant left in place 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- What is being tested?
- duration of standard antibiotic therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 Jul 2019to 31 Dec 2025
- Phase
- Interventional
- 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
- Spine surgery and intraoperative debridement with any technique
- At least 12 months of scheduled follow-up from hospitalization
- Bacterial spine infection of any nature, independently of implants or co-morbidities
Who cannot join
- Mycobacterial, fungal, nocardial, and Actinomyces infections in the spine
- Non-resected cancer in the infection site
- Bone marrow or recent solid organ transplant patient (Recent: <5 years)
- Any other infection in the patient requiring more than 6 weeks of antibiotic therapy
- More than three intraoperative debridements performed for spine infection
- Absence of at least one surgical intraoperative debridement of infection
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Balgrist University Hospital
Zurich, Canton of Zurich, 8008
About this study
Official title: Short Post-surgical Antibiotic Therapy in Spine Infections - a Pro-spective, Randomized, Unblinded, Non-inferiority Trial
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
- Six and twelve weeks of antibiotic therapy if there is an implant left in place
- Three and six weeks of antibiotic therapy if there is no implant left
- Conditions
- Infection
- Being tested
- duration of standard antibiotic therapy
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duration of standard antibiotic therapyDrug
Also called Co-amoxiclav, vancomycin
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: duration of standard antibiotic therapy |
| 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 Receives: Drug: duration of standard antibiotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission of infection at 12 months after treatment
no clinical and microbiological recurrences
Measured: 12 months after treatment
Secondary outcomes (3)
costs
total costs for treatment of infection
Measured: up to 12 months
duration of sick leave
duration of sick leave for treatment of infection
Measured: up to 12 months
length of hospital stay
number of days of hospital stay
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start31 Jul 2019
- Primary completion28 Feb 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization
- Masking
- None (open label)
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ilker Uckay, PD Dr med, Study director, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048304
- Sponsor's protocol ID
- SASI
- Status last verified
- Sep 2026
- First submitted
- 12 Jul 2019
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: identifying IPD will not be shared with other Researchers
Publications
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.
PubMed 41464652Betz 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 32028985
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Post-surgical Antibiotic Therapy in Spine Infections - a Pro-spective, Randomized, Unblinded, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT04048304
- Acronym / sponsor ID
- SASI
- Conditions
- Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 7 Aug 2019 (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.
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
- Six and twelve weeks of antibiotic therapy if there is an implant left in place
- Three and six weeks of antibiotic therapy if there is no implant left
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| short antibiotic therapy | Experimental | Drug: duration of standard antibiotic therapy3 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 | Drug: duration of standard antibiotic therapy6 weeks of antibiotic therapy with no implant in place 12 weeks of antibiotic therapy with implant left in place |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Spine surgery and intraoperative debridement with any technique
- At least 12 months of scheduled follow-up from hospitalization
- Bacterial spine infection of any nature, independently of implants or co-morbidities
Key exclusion criteria (6 listed)
- Mycobacterial, fungal, nocardial, and Actinomyces infections in the spine
- Non-resected cancer in the infection site
- Bone marrow or recent solid organ transplant patient (Recent: <5 years)
- Any other infection in the patient requiring more than 6 weeks of antibiotic therapy
- More than three intraoperative debridements performed for spine 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 |
|---|---|---|
| duration of standard antibiotic therapyAlso: Co-amoxiclav, vancomycinantibiotic 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. | Drug | long antibiotic therapy, short antibiotic therapy |
Primary outcome
Remission of infection at 12 months after treatment
Time frame: 12 months after treatment
no clinical and microbiological recurrences
3 secondary outcomes
costs
Time frame: up to 12 months
duration of sick leave
Time frame: up to 12 months
length of hospital stay
Time frame: up to 12 months
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 24 Sep 2026.
- Derived from this study: PubMed 41464652Zendeli 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.
- Derived from this study: 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.
- Individual participant dataSharing planned: No. identifying IPD will not be shared with other Researchers
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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 Uckay, PD Dr med study director
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 study testing duration of standard antibiotic therapy in people with Infection, 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 3 inclusion and 6 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 24 Sep 2026. 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.
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?
Remission of infection at 12 months after treatment (time frame: 12 months after treatment). 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 NCT04048304, which also lists 2 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 24 Sep 2026.