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

Primary Purpose

Infection

Status

Recruiting

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

duration of standard antibiotic therapy

About this trial

This is an interventional treatment trial for Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Balgrist University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

short antibiotic therapy

long antibiotic therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Remission of infection at 12 months after treatment

no clinical and microbiological recurrences

Secondary Outcome Measures

costs

total costs for treatment of infection

duration of sick leave

duration of sick leave for treatment of infection

length of hospital stay

number of days of hospital stay

Full Information

NCT ID

NCT04048304

First Posted

July 12, 2019

Last Updated

February 28, 2023

Sponsor

Balgrist University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04048304

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 31, 2019 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Balgrist University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 Six and twelve weeks of antibiotic therapy if there is an implant left in place Three and six weeks of antibiotic therapy if there is no implant left

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

1:1 randomization

Masking

None (Open Label)

Allocation

Randomized

Enrollment

236 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

short antibiotic therapy

Arm Type

Experimental

Arm Description

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

Arm Title

long antibiotic therapy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

duration of standard antibiotic therapy

Other Intervention Name(s)

Co-amoxiclav, vancomycin

Intervention Description

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.

Primary Outcome Measure Information:

Title

Remission of infection at 12 months after treatment

Description

no clinical and microbiological recurrences

Time Frame

12 months after treatment

Secondary Outcome Measure Information:

Title

costs

Description

total costs for treatment of infection

Time Frame

up to 12 months

Title

duration of sick leave

Description

duration of sick leave for treatment of infection

Time Frame

up to 12 months

Title

length of hospital stay

Description

number of days of hospital stay

Time Frame

up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ilker Uckay, PD Dr med

Phone

+41 44 386 1111

ilker.uckay@balgrist.ch

First Name & Middle Initial & Last Name or Official Title & Degree

Michael Betz, PD Dr med

Phone

+41 44 386 1111

michael.betz@balgrist.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ilker Uckay, PD Dr med

Organizational Affiliation

Balgrist University Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Balgrist University Hospital

City

Zürich

State/Province

Zurich

ZIP/Postal Code

8008

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ilker Uckay, MD

Phone

+41 44 386 37 05

ilker.uckay@balgrist.ch

First Name & Middle Initial & Last Name & Degree

Regula Schupbach

Phone

+41 44 510 73 75

regula.schuepbach@balgrist.ch

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

identifying IPD will not be shared with other Researchers

Citations:

PubMed Identifier

32028985

Citation

Betz M, Uckay I, Schupbach R, Grober T, Botter SM, Burkhard J, Holy D, Achermann Y, Farshad M. Short postsurgical antibiotic therapy for spinal infections: protocol of prospective, randomized, unblinded, noninferiority trials (SASI trials). Trials. 2020 Feb 6;21(1):144. doi: 10.1186/s13063-020-4047-3.

Results Reference

derived

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

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