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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.