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

Study Overview
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Brief Summary
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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 Six and twelve weeks of antibiotic therapy if there is an implant left in place Three and six weeks of antibiotic therapy if there is no implant left

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

Conditions
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Infection

Intervention / Treatment
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* Drug: duration of standard antibiotic therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 randomization
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: short antibiotic therapy<br>3 weeks of antibiotic therapy with no implant left in place 6 weeks of antibiotic therapy with implant left in place | Drug: duration of standard antibiotic therapy<br>* 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.<br>* Other names: Co-amoxiclav, vancomycin;|
| Active Comparator: long antibiotic therapy<br>6 weeks of antibiotic therapy with no implant in place 12 weeks of antibiotic therapy with implant left in place | Drug: duration of standard antibiotic therapy<br>* 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.<br>* Other names: Co-amoxiclav, vancomycin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission of infection at 12 months after treatment | no clinical and microbiological recurrences | 12 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| costs | total costs for treatment of infection | up to 12 months | 
| duration of sick leave | duration of sick leave for treatment of infection | up to 12 months | 
| length of hospital stay | number of days of hospital stay | up to 12 months |