NCT04048304

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: Balgrist University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-07-31
• Primary completion: 2025-02-28
• Completion: 2025-12-31
• First posted: 2019-08-07
• Last updated: 2025-02-21

Locations

1 site across 1 country: Switzerland