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

ConditionInfection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBalgrist University Hospital

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • duration of standard antibiotic therapy

Treatment groups

236 Participants
are divided into 2 treatment groups

Sponsors and collaborators