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NCT Number: NCT06601244

Pharmacokinetic Study in the Biliary Complications During Liver Transplantation

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.

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Key information

Conditions

Liver Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pharmacokinetic

Other

Biliary and blood concentration of the DALBAVANCINE

Primary outcomes

  1. Description of biliary diffusion of dalbavancin

    Time frame: At Month 2

    Measurement of DALBAVANCIN concentration in bile at Month 2

Secondary outcomes

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

    Time frame: at Month 2 and Month 6

    Good clinical progress is defined by the presence of 3 out of the following 3 criteria:

    • Disappearance of fever (T<38°C) or absence of fever spikes at Month 2 and Month 6 (in the absence of post-procedural biliary complications) or during follow-up.
    • Disappearance/regression of abdominal pain or absence of new abdominal pain at Month 2 and Month 6 after the endoscopic procedure (excluding post-procedural complications) or during follow-up (in the absence of another cause explaining the pain).
    • Disappearance/regression of jaundice or absence of new cutaneous-mucous jaundice at Month 2 and Month 6 after the endoscopic procedure or during follow-up (in the absence of another cause explaining the appearance of cutaneous-mucous jaundice).

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

    Time frame: at Month 2 and Month 6

    Good biological progress is defined by 3 out of the following 4 criteria:

    • Decrease in CRP by 50 mg/L, or a 20% decrease in CRP if the initial CRP is below 50 mg/L during follow-up at Month 2 and Month 6.
    • 50% decrease or normalization of bilirubin during follow-up at Month 2 and Month 6.
    • 50% decrease in cytolysis and cholestasis during follow-up at Month 2 and Month 6.
    • Disappearance of the causative pathogen in bile samples at 2 months after starting antibiotics.

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

    Time frame: at Month 2 and Month 6

    Good morphological progress is defined by:

    • Regression of bilioma or abscess size by >50% or 2 cm at 2 months of treatment (compared to the initial imaging at the time of complication) or disappearance of bilioma or hepatic abscess at 2 or 6 months.

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

    Time frame: at Month2, Month 4 and Month 6

    Poor antibiotic tolerance is defined by the occurrence of clinical or biological side effects summarized in the product characteristics classified as frequent in the VIDAL: diarrhea, nausea, headaches, asthenia, dizziness.

  5. Description of the antibiotic concentrations in bile relative to the MIC of the causative pathogens at Month 2.

    Time frame: at Month 2

    Measurement of DALBAVANCIN concentration, which must be greater than 10 times the MIC to be considered effective.

  6. Evaluation of the biliary concentration of DALBAVANCIN in comparison with the plasma concentration.

    Time frame: at Month 2 and Month 4

    Calculation of the ratio between biliary and plasma concentrations of DALBAVANCIN

  7. Evaluation of the effectiveness of DALBAVANCIN antibiotic treatment at Month 2 and Month 6.

    Time frame: at Month2 and Month 6

    • Description of the proportion of patients showing good clinical, morphological, and biological progress at Month 2 according to the plasma and biliary concentration ratio at Month 2, and the biliary concentration to MIC ratio of the causative pathogen at Month 2.
    • Description of the proportion of patients showing good clinical, morphological, and biological progress at Month 6 according to the plasma and biliary concentration ratio at Month 2, and the biliary concentration to MIC ratio of the causative pathogen.

Study contacts

Contact information is provided by the study sponsor or research team.

Saber TOUATI, PhD

CONTACT

[email protected]

0476765805

Salomé GALLET, MD

CONTACT

[email protected]

0476765291

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Pharmacokinetic Study of DALBAVANCINE in the Treatment of Biliary Complications During Liver Transplantation

Acronym: DALBATRANS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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