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Pharmacokinetic Study in the Biliary Complications During Liver Transplantation

Study acronym: DALBATRANS
StatusUnknown
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 19, 2024 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Not Yet Recruiting
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Liver transplantation is the last treatment for severe liver diseases such as advanced cirrhosis or fulminant hepatitis. This is a heavy treatment can be associated with numerous complications, particularly biliary ones. The management of biliary complications is mixed, combining endoscopic treatment with biliary protheses and antibiotics. A cohort study carried out at the Grenoble Alpes University Hospital showed a high prevalence of Enterococcus Faecium during these biliary complications. This epidemiology complicates the treatment, because it presents a natural resistance to cephalosporins and penicillin (60% of resistance to amoxicillin in Grenoble hospital), the first line treatment for biliary infection. Antibiotic used to treat this infection can be DALBAVANCIN, which are compatible with outpatient follow-up. Although the results are interesting in term of efficacy, no study has investigated the biliary diffusion of this antibiotic.
Trial Details
NCT Number NCT06601244
Lead Sponsor University Hospital, Grenoble
Conditions
(from sponsor)		 Liver Transplantation
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov