Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04048304

Short Post-surgical Antibiotic Therapy in Spine Infections - a Prospective, Randomized, Unblinded, Non-inferiority Trial

Led by Balgrist University Hospital · Updated on 2025-02-21

236

Participants Needed

1

Research Sites

335 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Short Post-surgical Antibiotic Therapy in Spine Infections - a Prospective, Randomized, Unblinded, Non-inferiority Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Balgrist University Hospital

Zurich, Canton of Zurich, Switzerland, 8008

Actively Recruiting

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Research Team

I

Ilker Uckay, PD Dr med

CONTACT

M

Michael Betz, PD Dr med

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Short Post-surgical Antibiotic Therapy in Spine Infections - a Prospective, Randomized, Unblinded, Non-inferiority Trial | DecenTrialz