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NCT07158502
Antimicrobial Strategy for Device Implantation
trial testing TauroPace Cohort in CIED-related Infections in 1,000 participants. Not yet recruiting.
30 September 2027
Quick facts
| Lead sponsor | University of Calabria |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 1,000 |
| Start date | 1 September 2025 |
| Primary completion | 30 September 2027 |
| Estimated completion | 31 December 2027 |
Drugs / interventions tested
- TauroPace Cohort — full drug profile →
Conditions studied
- CIED-related Infections — all drugs for CIED-related Infections →
Sponsor
University of Calabria
Who can join
18 and older, any sex, with CIED-related Infections. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Infections associated with cardiovascular implantable electronic devices (CIEDs) represent one of the major postoperative complications in interventional cardiology. These infections-including lead-related endocarditis, subcutaneous pocket infections, and sepsis-are characterized by high rates of morbidity, mortality, and healthcare costs. According to current epidemiological data, the incidence of CIED-related infections is estimated to be around 0.5-2% within the first 12 months and may rise to 5% over long-term follow-up. These infections are associated with a mortality rate of up to 34% and often require device explantation and prolonged antibiotic therapy. TauroPace™ is an antimicrobial solution based on taurolidine, a broad-spectrum, non-antibiotic agent that acts by disrupting bacterial biofilms and preventing microbial colonization. Taurolidine has a favorable safety profile, does not induce antibiotic resistance, and is already approved in Europe as a CE-marked medical device (Directive 93/42/EEC). The application of TauroPace™ to the surface of CIEDs prior to implantation may significantly reduce the incidence of infections compared to the current standard, which consists of irrigating the device pocket with sterile saline solution. The aim of this study is to rigorously and systematically evaluate the effectiveness of TauroPace™ compared to standard clinical practice.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07158502
- Europe PMC full search
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Related trials
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Currently open trials in the same condition.
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Other University of Calabria trials
Trials by the same sponsor.
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- NCT06404021 — Electronic Device Implantation Through Remote Guidance · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07158502 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Calabria
- Last refreshed: 5 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07158502.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing