New treatment option for Infection
Official title Short Post-surgical Antibiotic Therapy in Spine Infections - a Prospective, Randomized, Unblinded, Non-inferiority Trial
ClinicalTrials.gov ID: NCT04048304
What this study is testing
What is duration of standard antibiotic therapy?
duration of standard antibiotic therapy is an investigational medicine, being studied as a potential treatment for infection.
Also referred to as Co-amoxiclav, vancomycin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Zurich, Canton of Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zurich, Canton of Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.