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

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04048304
• Other study ID #: SASI
• Status: Recruiting
• Phase: N/A
• Start date: July 31, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Balgrist University Hospital
• Contact: Ilker Uckay, PD Dr med
• Phone: +41 44 386 1111
• Email: ilker.uckay[@]balgrist.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 236
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infections

Intervention

Drug:
• duration of standard antibiotic therapy
antibiotic therapy for spine infections. 3 vs 6 weeks if no implant left in place. 6 vs 12 weeks if implant left in place. The antibiotic agents used are officially indicated for orthopedic infections, including spine infections and available in Switzerland since decades. Standard dosing will be applied and only modified according to the patient's co-morbidities, intolerances and weight.

Locations

Country	Name	City	State
Switzerland	Balgrist University Hospital	Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission of infection at 12 months after treatment	no clinical and microbiological recurrences	12 months after treatment
Secondary	costs	total costs for treatment of infection	up to 12 months
Secondary	duration of sick leave	duration of sick leave for treatment of infection	up to 12 months
Secondary	length of hospital stay	number of days of hospital stay	up to 12 months