临床试验/NCT04048304

NCT04048304招募中不适用

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

Balgrist University Hospital1 个研究点分布在 1 个国家目标入组 236 人开始时间: 2019年7月31日最近更新: 2025年2月21日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 236
试验地点: 1
主要终点: Remission of infection at 12 months after treatment

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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

排除标准

•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

研究组 & 干预措施

short antibiotic therapy

Experimental

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

干预措施: duration of standard antibiotic therapy (Drug)

long antibiotic therapy

Active Comparator

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

干预措施: duration of standard antibiotic therapy (Drug)

结局指标

主要结局

Remission of infection at 12 months after treatment

时间窗: 12 months after treatment

no clinical and microbiological recurrences

次要结局

costs(up to 12 months)
duration of sick leave(up to 12 months)
length of hospital stay(up to 12 months)

研究者

发起方

Balgrist University Hospital

申办方类型

Other

责任方

Sponsor

研究点 (1)

Loading locations...

相似试验

尚未招募

4 期

Reduction of Antibiotherapy Duration for Infections on Implantable Extra Cardiac Devices LeadsCardiac Devices Infection

NCT06203769Assistance Publique - Hôpitaux de Paris500

Unknown

4 期

Struvite Stones Antibiotic StudyKidney Stones

NCT02375295University of British Columbia28

已完成

3 期

Duration of Antibiotic Therapy in the Treatment of Severe Postoperative Peritonitis Admitted in ICUPostoperative Peritonitis

NCT01311765Assistance Publique - Hôpitaux de Paris244

尚未招募

1 期

Comparison of composite and simple mesh for inguinal hernia repair of patients

CTRI/2019/06/019871ady Hardinge Medical College

尚未招募

4 期

Randomized Controlled Trial of Duration of Antibiotic Prophylaxis in Head and Neck Surgery with Free Flap Reconstruction, HEDAX Trial

ACTRN12624000370505The Royal Melbourne Hospital, Melbourne Health526