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

Recruiting now · Not applicable

Conditions studied: Infection

In brief

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

Key facts

Study ID

NCT04048304

Run by

Balgrist University Hospital

People needed

236

Starts

2019-07-31

Expected to finish

2025-12-31

Last updated by the study team

2025-02-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Balgrist University Hospital — Zurich, Canton of Zurich, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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