Abstract
BackgroundThere are several open scientific questions regarding the optimal antibiotic treatment of spinal infections (SIs) with or without an implant. The duration of postsurgical antibiotic therapy is debated.MethodsWe will perform two unblinded randomized controlled trials (RCTs). We hypothesize that shorter durations of systemic antibiotic therapy after surgery for SI are noninferior (10% margin, 80% power, α = 5%) to existing (long) treatment durations. The RCTs allocate the participants to two arms of 2 × 59 episodes each: 3 vs. 6 weeks of targeted postsurgical systemic antibiotic therapy for implant-free SIs or 6 vs. 12 weeks for implant-related SIs. This equals a total of 236 adult SI episodes (randomization scheme 1:1) with a minimal follow-up of 12 months. All participants receive concomitant multidisciplinary surgical, re-educational, internist, and infectious disease care. We will perform three interim analyses that are evaluated, in a blinded analysis, by an independent study data monitoring committee. Besides the primary outcome of remission, we will also assess adverse events of antibiotic therapy, changes of the patient’s nutritional status, the influence of immune suppression, total costs, functional scores, and the timely evolution of the (surgical) wounds. We define infection as the presence of local signs of inflammation (pus, wound discharge, calor, and rubor) together with microbiological evidence of the same pathogen(s) in at least two intraoperative samples, and we define remission as the absence of clinical, laboratory, and/or radiological evidence of (former or new) infection.DiscussionProvided that there is adequate surgical debridement, both RCTs will potentially enable prescription of less antibiotics during the therapy of SI, with potentially less adverse events and reduced overall costs.Trial registrationClinicalTrials.gov, NCT04048304. Registered on 5 August 2019.Protocol version2, 5 July 2019.
Highlights
There are several open scientific questions regarding the optimal antibiotic treatment of spinal infections (SIs) with or without an implant
If there is no benefit to long duration antibiotic therapy, it would be important to limit the use of antibiotic agents to avoid furthering the problem of antibiotic resistance and adverse events, because the incidence of adverse events related to antibiotic therapy and costs genuinely increase with longer duration of antimicrobial administration [5]
The primary study objective is to evaluate if 6 weeks of systemic and targeted antibiotic therapy postoperatively is not inferior to 12 weeks in cases of infection in spinal implant-associated infections when spine implants are left in place
Summary
Setting The Balgrist University Hospital (incorporating the University Spine Center Zürich) is a tertiary referral center for SI that is affiliated with the University of Zurich, Switzerland. Treatment and outcome: number of surgeries to treat infection; total duration of antibiotic therapy; duration, agent, and dose of intravenous and oral antibiotic therapy; intraoperative vancomycin powder; woundhealing problems; presence and duration of vacuum-assisted negative pressure therapy; adverse events; clinical or and microbiological recurrence; date and reasons for rehospitalization and retreatment; follow-up data; fatalities; Nutritional Risk Screening (NRS 2002); neck disability index (NDI); or Oswestry low back disability index (ODI). The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) diagram in Fig. 3 shows the timely assessments that are identical for both RCTs. Antibiotic agents The antibiotic therapy is prescribed by infectious disease physicians with experience in orthopedic infections, the surgeons in charge of the patient, and/or the internists. Concerning the RCTs, a theoretical risk could be a higher incidence of recurrences in the corresponding short-term antibiotic arms
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