Health TrialsbyHealthPanel

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

ConditionInfection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBalgrist University Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • duration of standard antibiotic therapy

    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.

Treatment groups

236 Participants
are divided into 2 treatment groups
Group A: short antibiotic therapyExperimental treatment 1 intervention
Group B: long antibiotic therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Remission of infection at 12 months after treatment

no clinical and microbiological recurrences

Time frame
12 months after treatment

Secondary outcomes

1

costs

total costs for treatment of infection

Time frame
up to 12 months
2

duration of sick leave

duration of sick leave for treatment of infection

Time frame
up to 12 months
3

length of hospital stay

number of days of hospital stay

Time frame
up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Balgrist University Hospital

Lead sponsor

Source ClinicalTrials.gov
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