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

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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. 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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Balgrist University Hospital
• Treatments: Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antitubercular; Vancomycin

Criteria

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