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

NCT04048304 | Recruiting DMC

• 1 other identifier: SASI
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief 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. 1.Six and twelve weeks of antibiotic therapy if there is an implant left in place
2. 2.Three and six weeks of antibiotic therapy if there is no implant left

Conditions

Infection

Outcome Measures

Primary Outcomes (1)

• Remission of infection at 12 months after treatment

  no clinical and microbiological recurrences

  12 months after treatment

Secondary Outcomes (3)

• costs

  up to 12 months

• duration of sick leave

  up to 12 months

• length of hospital stay

  up to 12 months

Study Arms (2)

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

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

Drug: duration of standard antibiotic therapy

Interventions

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.

Also known as: Co-amoxiclav, vancomycin

long antibiotic therapy; short antibiotic therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Balgrist University Hospital: lead

Study Sites (1)

Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

RECRUITING

Related Publications (2)

• 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.

  PMID: 41464652 DERIVED

• 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.

  PMID: 32028985 DERIVED

MeSH Terms

Conditions

Infections

Interventions

Amoxicillin-Potassium Clavulanate Combination; Vancomycin

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Ilker Uckay, PD Dr med

  Balgrist University Hospital

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: August 7, 2019
• Study Start: July 31, 2019
• Primary Completion: February 28, 2025
• Study Completion: December 31, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)