Pharmacokinetic Study in the Biliary Complications During Liver Transplantation

NCT ID: NCT06601244

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-15
• Study Completion Date: 2025-09-30

Brief Summary

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.

Conditions

Liver Transplantation

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Pharmacokinetic

Biliary and blood concentration of the DALBAVANCINE

Intervention Type: OTHER

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.

• Discontinuation of antibiotic therapy before the completion of biliary dosage measurements.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Salomé GALLET, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Grenoble Alpes

Locations

University Hospital Of Grenoble

Grenoble, , France

Countries

France

Central Contacts

Salomé GALLET, MD

Role: CONTACT

sgallet@chu-grenoble.fr

0476765291

Saber TOUATI, PhD

Role: CONTACT

stouati1@chu-grenoble.fr

0476765805

Facility Contacts

Salomé GALLET, MD

Role: primary

sgallet@chu-grenoble.fr

+33 (0)4 76 76 52 91

Zakaria Maghlaoua, MD

Role: backup

ZMaghlaoua@chu-grenoble.fr

Other Identifiers

38RC24.0165

Identifier Type: -

Identifier Source: org_study_id