Pharmacokinetic Study in the Biliary Complications During Liver Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pharmacokinetic.
- Who it may be relevant to
- Registry conditions: Liver Transplantation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pharmacokinetic Study of DALBAVANCINE in the Treatment of Biliary Complications During Liver Transplantation
Overview
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.
Detailed description
This is a prospective observational descriptive monocentric study. As the biliary and blood samples taken are not part of standard patient management, this is a type 3 study involving human subjects.
In order to ascertain the value of antibiotic therapy with DALBAVANCINE for the treatment of biliary complications, it is important first to study the pharmacokinetics of these antibiotics to confirm their proper distribution at this site.
As concerns the study population, all liver transplant patients with biliary complications are eligible for inclusion. After diagnosis of a biliary complication and inclusion, the patient undergoes biliairy drainage (endoscopic or radiological) with bacteriological examination and antibiotic dosage in bile and blood.
Biliary drainage consists of placing biliary protheses repeatedly every 2 months for a year of follow-up. Endoscopic retrograde cholangiopancreatography allow an access to the biliary duct to change protheses and make bacteriological, mycological and antibiotic sample.
The antibiotic treatment consists of one perfusion of 1500 mg of DALBAVANCINE at J1, J7 and M2 after the biliary complication.
Plasma and biliary assays will be checked at M2 and M4 of treatment. These tests will be carried out at the time of changing biliary stents, which are part of routine care for these patients.
Clinical, biological and morphological trends are monitored for 6 months.
Interventions
- Other Pharmacokinetic
Biliary and blood concentration of the DALBAVANCINE
Primary outcome measures
- Description of biliary diffusion of dalbavancin [Time frame: At Month 2]
Secondary outcome measures (7)
- Description of the proportion of patients showing good clinical progress at Month 2 and Month 6. [Time frame: at Month 2 and Month 6]
- Description of the proportion of patients showing good biological progress at Month 2 and Month 6. [Time frame: at Month 2 and Month 6]
- Description of the proportion of patients showing good morphological progress at Month 2 and Month 6. [Time frame: at Month 2 and Month 6]
- Record the occurrence of serious adverse events to evaluate the tolerance of the antibiotic therapy. [Time frame: at Month2, Month 4 and Month 6]
- Description of the antibiotic concentrations in bile relative to the MIC of the causative pathogens at Month 2. [Time frame: at Month 2]
- Evaluation of the biliary concentration of DALBAVANCIN in comparison with the plasma concentration. [Time frame: at Month 2 and Month 4]
- Evaluation of the effectiveness of DALBAVANCIN antibiotic treatment at Month 2 and Month 6. [Time frame: at Month2 and Month 6]
Eligibility criteria
Inclusion criteria
- Adult
- Social security coverage
- Liver transplant recipient
- Hospitalized at CHUGA
- Presenting biliary complications following liver transplantation, confirmed morphologically by ultrasound, CT scan, or liver MRI:
- Biliomas / bilioperitoneum
- Hepatic abscess as described by the radiologist
- Undergoing biliary endoscopy or radiological drainage following the initiation of antibiotic therapy (between H0-H96 and 6 weeks +/- 2 weeks)
- Having expressed their non-opposition to participate in this study.
Exclusion criteria
- Patients under guardianship or deprived of liberty. Persons referred to in Articles L1121-5 to L1121-8 of the Public Health Code.
- Patients not affiliated with social security.
- Contraindication to the use of DALBAVANCIN.
Secondary exclusion criteria:
\- Discontinuation of antibiotic therapy before the completion of biliary dosage measurements.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
France · 1 center
- University Hospital Of Grenoble — Grenoble
Identifiers
NCT: NCT06601244 · 38RC24.0165