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NCT Number: NCT04048304

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

Recruiting

Interested in participating?

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Key information

Conditions

Infection Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Co-amoxiclav, vancomycin

Primary outcomes

  1. Remission of infection at 12 months after treatment

    Time frame: 12 months after treatment

    no clinical and microbiological recurrences

Secondary outcomes

  1. costs

    Time frame: up to 12 months

    total costs for treatment of infection

  2. duration of sick leave

    Time frame: up to 12 months

    duration of sick leave for treatment of infection

  3. length of hospital stay

    Time frame: up to 12 months

    number of days of hospital stay

Study contacts

Contact information is provided by the study sponsor or research team.

Ilker Uckay, PD Dr med

CONTACT

[email protected]

+41 44 386 1111

Michael Betz, PD Dr med

CONTACT

[email protected]

+41 44 386 1111

Sponsors and collaborators

Lead sponsor

Balgrist University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2019
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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