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

Balgrist University Hospital

Status: Enrolling

Conditions: Infection

Treatments: Drug: duration of standard antibiotic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04048304

SASI

Details and patient eligibility

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

Enrollment: 236 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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236 participants in 2 patient groups

short antibiotic therapy

Experimental group

Description:

3 weeks of antibiotic therapy with no implant left in place 6 weeks of antibiotic therapy with implant left in place

Treatment:

Drug: duration of standard antibiotic therapy

long antibiotic therapy

Active Comparator group

Description:

6 weeks of antibiotic therapy with no implant in place 12 weeks of antibiotic therapy with implant left in place

Treatment:

Drug: duration of standard antibiotic therapy