Comparing short and long antibiotic treatments for infected orthopedic implants
Short Against Long Antibiotic Therapy for Infected Orthopedic Sites
This study is testing whether shorter or longer courses of antibiotics work better for people with infections related to orthopedic implants, whether the implant stays in or is removed.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Balgrist University Hospital Academic / other |
| Locations | 1 site (Zurich) |
| Trial ID | NCT05499481 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the optimal duration of antibiotic therapy for orthopedic infections associated with implants. It consists of two randomized controlled trials: one for cases where the infected implant remains in place and another for cases where the implant is removed. Participants will be randomized to receive either a shorter or longer course of antibiotics, with the aim of determining the most effective treatment duration. The study seeks to expand knowledge beyond current practices, particularly in orthopedic and hand surgery.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with orthopedic bone and implant infections requiring surgical debridement.
Not a fit: Patients with infections caused by mycobacteria, fungi, or those with purely soft tissue infections will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to shorter and more effective antibiotic treatments for patients with orthopedic infections, reducing side effects and healthcare costs.
How similar studies have performed: Previous studies have suggested that shorter antibiotic durations may be effective, indicating potential for success in this trial's approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years on admission * Orthopedic bone and implant infections including musculoskeletal grafts * Intraoperative debridement with any surgical technique * 12 months of scheduled follow-up from hospitalization * Bacterial orthopedic infections of any nature * First or second episode of infection Exclusion Criteria: * Mycobacterial, fungal, nocardial, and Actinomyces infections * Purely soft tissue infections * Non-resected cancer in the infection site * Purely intrasynovial infections (native joint septic arthritis) * More than three debridements performed for infection * Absence of at least one surgical intraoperative debridement * Spine infections (investigated in another trial)10 * Diabetic foot infections (investigated in another trial)7 * Documented endocarditis according to the Duke criteria * At least 2 prior infection episodes at the actual infection site
Where this trial is running
Zurich
- Balgrist University Hospital — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Ilker Uçkay, Professor — Balgrist University Hospital
- Study coordinator: Ilker Uçkay, Professor
- Email: ilker.uckay@balgrist.ch
- Phone: ++41 44 386 37 05
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.