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

Not Applicable

Recruiting

• Conditions: Infection
• Interventions: Drug: duration of standard antibiotic therapy

• Registration Number: NCT04048304
• Lead Sponsor: Balgrist University Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-12
• Study Start: 2019-07-31
• Study First Submitted QC: 2019-08-05
• Study First Posted: 2019-08-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21
• Primary Completion: 2025-02-28
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 236

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
short antibiotic therapy	duration of standard antibiotic therapy	3 weeks of antibiotic therapy with no implant left in place 6 weeks of antibiotic therapy with implant left in place
long antibiotic therapy	duration of standard antibiotic therapy	6 weeks of antibiotic therapy with no implant in place 12 weeks of antibiotic therapy with implant left in place

Primary Outcome Measures

Name	Time	Method
Remission of infection at 12 months after treatment	12 months after treatment	no clinical and microbiological recurrences

Secondary Outcome Measures

Name	Time	Method
costs	up to 12 months	total costs for treatment of infection
duration of sick leave	up to 12 months	duration of sick leave for treatment of infection
length of hospital stay	up to 12 months	number of days of hospital stay

Trial Locations

Locations (1)

Balgrist University Hospital; 🇨🇭 Zürich, Zurich, Switzerland