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New treatment option for Endocarditis, Bacterial
Official title New Treatment of Cardiac Device Infections; Immediate Reimplantation After Removal of Infected System
ClinicalTrials.gov ID: NCT06250985
What this study is testing
- What it's testing
- The goal of this randomized clinical trials is to ascertain the safety and efficacy of immediate reimplantation of cardiac electronic implantable devices in patients with endocarditis and device-infections, compared to standard care, i.e. reimplantation at a later procedure date.
- Phase 3: a large, late-stage study
- 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 to 110
You may be able to join if
- Culture positive or negative infection of a CIED acording to PI
- Indication for removal of device
- Clinical indication of device removal of existing device (concurrent left-sided IE is not a contraindication).
- Indication for reimplantation of new device
- A minimum of 3 days of sufficient antibiotic treatment (intravenous or oral) has been administered and/or culture negative antibiotic regimen have...
You likely can't join if
- Immunoincompetence (active chemotherapy or prednisone treatment \> 20mg/day
- Device-infection within last 6 months (relaps)
- Septic shock
- Stabilization criteria not fulfilled after 10 days of suficient antibiotic treatment
See the full eligibility criteria
- Culture positive or negative infection of a CIED acording to PI
- Indication for removal of device
- Clinical indication of device removal of existing device (concurrent left-sided IE is not a contraindication).
- Indication for reimplantation of new device
- A minimum of 3 days of sufficient antibiotic treatment (intravenous or oral) has been administered and/or culture negative antibiotic regimen have been adminstered until blood culture is examined.
- stabilization criteria fulfilled i.e. I) negativ blood cultures, II) WBC \< 15 mia/L or reduction of min. 25% and III) CRP \<50 or min. 25% reduction.
- Immunoincompetence (active chemotherapy or prednisone treatment \> 20mg/day
- Device-infection within last 6 months (relaps)
- Septic shock
- Stabilization criteria not fulfilled after 10 days of suficient antibiotic treatment
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
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 to 110 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark. 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.