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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-31

Study Completion Date

2025-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 randomization

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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short antibiotic therapy

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

Group Type EXPERIMENTAL

duration of standard antibiotic therapy

Intervention Type DRUG

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.

long antibiotic therapy

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

Group Type ACTIVE_COMPARATOR

duration of standard antibiotic therapy

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Co-amoxiclav, vancomycin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No