Shortening antibiotic therapy after spine surgery for infections
Short Post-surgical Antibiotic Therapy in Spine Infections - a Pro-spective, Randomized, Unblinded, Non-inferiority Trial
NA · Balgrist University Hospital · NCT04048304
This study is testing if shorter courses of antibiotics after spine surgery for infections can work just as well as longer ones for people with or without implants.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 236 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Balgrist University Hospital (other) |
| Locations | 1 site (Zurich, Canton of Zurich) |
| Trial ID | NCT04048304 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the optimal duration of antibiotic therapy following surgical debridement for spine infections. Participants will be randomly assigned to receive either six or twelve weeks of antibiotics if an implant is present, or three or six weeks if no implant is used. The study aims to determine if shorter antibiotic courses can be as effective as longer ones, thereby potentially reducing antibiotic exposure and associated side effects. The trial is designed as a prospective, randomized, unblinded, non-inferiority trial to assess treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients undergoing spine surgery with bacterial infections who require surgical debridement.
Not a fit: Patients with mycobacterial, fungal, or other specific infections, as well as those with certain comorbidities or extensive prior surgeries, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to shorter antibiotic treatment durations without compromising patient outcomes, reducing the risk of antibiotic resistance.
How similar studies have performed: Other studies have explored antibiotic duration in various infections, but this specific approach in spine infections is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Zurich, Canton of Zurich
- Balgrist University Hospital — Zurich, Canton of Zurich, Switzerland (RECRUITING)
Study contacts
- Study coordinator: Ilker Uckay, PD Dr med
- Email: ilker.uckay@balgrist.ch
- Phone: +41 44 386 1111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infection