Infection
Conditions
Brief 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
Interventions
DRUGduration 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.
Sponsors
Balgrist University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1:1 randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remission of infection at 12 months after treatment | 12 months after treatment | no clinical and microbiological recurrences |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| costs | up to 12 months | total costs for treatment of infection |
| duration of sick leave | up to 12 months | duration of sick leave for treatment of infection |
| length of hospital stay | up to 12 months | number of days of hospital stay |
Countries
Switzerland
Contacts
Primary ContactIlker Uckay, PD Dr med
Backup ContactMichael Betz, PD Dr med
Outcome results
None listed