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CompletedNCT04048304Updated Sep 24, 2026

Short Post-surgical Antibiotic Therapy in Spine Infections - a Prospective, Randomized, Unblinded, Non-inferiority Trial

An interventional study of duration of standard antibiotic therapy in Infection, sponsored by Balgrist University Hospital. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Balgrist University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
271
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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. Three and six weeks of antibiotic therapy if there is no implant left
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Conditions studied

  • Infection

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In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 271 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Balgrist University Hospital is the lead sponsor of 80 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
271 participants (actual)

Study arms

  • Experimental
    short antibiotic therapy

    3 weeks of antibiotic therapy with no implant left in place 6 weeks of antibiotic therapy with implant left in place

    Drug: duration of standard antibiotic therapy

  • Active comparator
    long antibiotic therapy

    6 weeks of antibiotic therapy with no implant in place 12 weeks of antibiotic therapy with implant left in place

    Drug: duration of standard antibiotic therapy

Interventions

  • Drugduration of standard antibiotic therapy

    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.

    Also known as: Co-amoxiclav, vancomycin

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What researchers measure

Primary outcomes

  1. Remission of infection at 12 months after treatment

    no clinical and microbiological recurrences

    Time frame: 12 months after treatment

Secondary outcomes

  1. costs

    total costs for treatment of infection

    Time frame: up to 12 months

  2. duration of sick leave

    duration of sick leave for treatment of infection

    Time frame: up to 12 months

  3. length of hospital stay

    number of days of hospital stay

    Time frame: up to 12 months

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Study locations

1 site
  • Balgrist University Hospital
    Zurich, Canton of Zurich 8008, Switzerland
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References and documents

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 41464652 ↗
  • 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. PubMed 32028985 ↗

Study documents

  • Statistical analysis plan · May 24, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — identifying IPD will not be shared with other Researchers

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04048304
Lead sponsor
Balgrist University Hospital
Responsible party
Sponsor
First posted
Aug 7, 2019
Start date
Jul 31, 2019
Primary completion
Feb 28, 2025
Completion
Dec 31, 2025
Last update
Sep 24, 2026

Study contacts

Ilker Uckay, PD Dr med
study director · Balgrist University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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