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

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

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

Study Overview

• Status: Recruiting
• Conditions: Infection
• Intervention / Treatment: Drug: duration of standard antibiotic therapy

• Study Type: Interventional
• Enrollment (Anticipated): 236
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ilker Uckay, PD Dr med; Phone Number: +41 44 386 1111; Email: ilker.uckay@balgrist.ch
• Study Contact Backup: Name: Michael Betz, PD Dr med; Phone Number: +41 44 386 1111; Email: michael.betz@balgrist.ch

Study Locations

• Switzerland
  • Zurich
    • Zürich, Zurich, Switzerland, 8008
      • Recruiting
      • Balgrist University Hospital
      • Contact: Ilker Uckay, MD; Phone Number: +41 44 386 37 05; Email: ilker.uckay@balgrist.ch
      • Contact: Regula Schupbach; Phone Number: +41 44 510 73 75; Email: regula.schuepbach@balgrist.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.; Other Names: Co-amoxiclav, vancomycin
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; 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.; Other Names: Co-amoxiclav, vancomycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remission of infection at 12 months after treatment	no clinical and microbiological recurrences	12 months after treatment

Secondary Outcome Measures

Outcome Measure	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	up to 12 months
length of hospital stay	number of days of hospital stay	up to 12 months

Collaborators and Investigators

• Sponsor: Balgrist University Hospital
• Investigators: Study Director: Ilker Uckay, PD Dr med, Balgrist University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: July 12, 2019
• First Submitted That Met QC Criteria: August 5, 2019
• First Posted (Actual): August 7, 2019

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Anti-Infective Agents; Vancomycin; Anti-Bacterial Agents
• Other Study ID Numbers: SASI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: identifying IPD will not be shared with other Researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No