NCT04048304 Short Post-surgical Antibiotic Therapy in Spine Infections - a Prospective, Randomized, Unblinded, Non-inferiority Trial
| NCT ID | NCT04048304 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Balgrist University Hospital |
| Condition | Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 236 participants |
| Start Date | 2019-07-31 |
| Primary Completion | 2025-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 236 participants in total. It began in 2019-07-31 with a primary completion date of 2025-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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
Contact & Investigator
Ilker Uckay, PD Dr med
STUDY DIRECTOR
Balgrist University Hospital
Frequently Asked Questions
Who can join the NCT04048304 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04048304 currently recruiting?
Yes, NCT04048304 is actively recruiting participants. Contact the research team at ilker.uckay@balgrist.ch for enrollment information.
Where is the NCT04048304 trial being conducted?
This trial is being conducted at Zurich, Switzerland.
Who is sponsoring the NCT04048304 clinical trial?
NCT04048304 is sponsored by Balgrist University Hospital. The principal investigator is Ilker Uckay, PD Dr med at Balgrist University Hospital. The trial plans to enroll 236 participants.