Status:
RECRUITING
Short Post-surgical Antibiotic Therapy in Spine Infections - a Prospective, Randomized, Unblinded, Non-inferiority Trial
Lead Sponsor:
Balgrist University Hospital
Conditions:
Infection
Eligibility:
All Genders
18+ years
Phase:
NA
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; rando...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT04048304
Start Date
July 31 2019
End Date
December 31 2025
Last Update
February 21 2025
Active Locations (1)
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1
Balgrist University Hospital
Zurich, Canton of Zurich, Switzerland, 8008