Pharmacokinetic Study in the Biliary Complications During Liver Transplantation

NCT06601244 | Not Yet Recruiting

• 1 other identifier: 38RC24.0165
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplantation

Keywords

liver transplantation; Biliary complications; DALBAVANCINE; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Description of biliary diffusion of dalbavancin

  Measurement of DALBAVANCIN concentration in bile at Month 2

  At Month 2

Secondary Outcomes (7)

• Description of the proportion of patients showing good clinical progress at Month 2 and Month 6.

  at Month 2 and Month 6

• Description of the proportion of patients showing good biological progress at Month 2 and Month 6.

  at Month 2 and Month 6

• Description of the proportion of patients showing good morphological progress at Month 2 and Month 6.

  at Month 2 and Month 6

• Record the occurrence of serious adverse events to evaluate the tolerance of the antibiotic therapy.

  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.

  at Month 2

Interventions

Pharmacokinetic OTHER

Biliary and blood concentration of the DALBAVANCINE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hepatic or biliary tract infection requiring prolonged antibiotic therapy with DALBAVANCINE. Patients who have liver transplantation complicated by a bilioma or liver abscess.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital Of Grenoble

Grenoble, 38700, France

Location

MeSH Terms

Interventions

Pharmacogenomic Variants

Intervention Hierarchy (Ancestors)

Polymorphism, Genetic; Genetic Variation; Genetic Phenomena

Study Officials

• Salomé GALLET, MD

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salomé GALLET, MD

CONTACT

0476765291; sgallet@chu-grenoble.fr

Saber TOUATI, PhD

CONTACT

0476765805; stouati1@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: September 19, 2024
• Study Start: September 15, 2024
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

FR (1)