Short Post-surgical Antibiotic Therapy in Spine Infections – a Prospective, Randomized, Unblinded, Non-inferiority Trial
Overview
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
Full Title of Study: “Short Post-surgical Antibiotic Therapy in Spine Infections – a Pro-spective, Randomized, Unblinded, Non-inferiority Trial”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 31, 2023
Interventions
- 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.
Arms, Groups and Cohorts
- 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
- 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
Clinical Trial Outcome Measures
Primary Measures
- Remission of infection at 12 months after treatment
- Time Frame: 12 months after treatment
- no clinical and microbiological recurrences
Secondary Measures
- costs
- Time Frame: up to 12 months
- total costs for treatment of infection
- duration of sick leave
- Time Frame: up to 12 months
- duration of sick leave for treatment of infection
- length of hospital stay
- Time Frame: up to 12 months
- number of days of hospital stay
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Balgrist University Hospital
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Ilker Uckay, PD Dr med, Study Director, Balgrist University Hospital
- Overall Contact(s)
- Ilker Uckay, PD Dr med, +41 44 386 1111, ilker.uckay@balgrist.ch
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