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

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ClinicalTrials.gov Identifier: NCT04048304
Recruitment Status : Not yet recruiting
First Posted : August 7, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Balgrist University Hospital

Brief 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

Condition or disease Intervention/treatment Phase
Infection Drug: duration of standard antibiotic therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 randomization
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short Post-surgical Antibiotic Therapy in Spine Infections - a Pro-spective, Randomized, Unblinded, Non-inferiority Trial
Estimated Study Start Date : July 31, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: short antibiotic therapy
3 weeks of antibiotic therapy with no implant left in place 6 weeks of antibiotic therapy with implant left in place
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.
Other Name: Co-amoxiclav, vancomycin

Active Comparator: long antibiotic therapy
6 weeks of antibiotic therapy with no implant in place 12 weeks of antibiotic therapy with implant left in place
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.
Other Name: Co-amoxiclav, vancomycin




Primary Outcome Measures :
  1. Remission of infection at 12 months after treatment [ Time Frame: 12 months after treatment ]
    no clinical and microbiological recurrences


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04048304


Contacts
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Contact: Ilker Uckay, PD Dr med +41 44 386 1111 ilker.uckay@balgrist.ch
Contact: Michael Betz, PD Dr med +41 44 386 1111 michael.betz@balgrist.ch

Sponsors and Collaborators
Balgrist University Hospital
Investigators
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Study Director: Ilker Uckay, PD Dr med Balgrist University Hospital

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Responsible Party: Balgrist University Hospital
ClinicalTrials.gov Identifier: NCT04048304     History of Changes
Other Study ID Numbers: SASI
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: identifying IPD will not be shared with other Researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents