Liver TransplantationDALBATRANSNCT06601244
Pharmacokinetic Study in the Biliary Complications During Liver Transplantation
An observational study of Liver Transplantation, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Pharmacokinetic
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2024to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital Of Grenoble
Grenoble, 38700
Salomé GALLET, MD, +33 (0)4 76 76 52 91, sgallet@chu-grenoble.fr
Zakaria Maghlaoua, MD, ZMaghlaoua@chu-grenoble.fr
About this study
Official title: Pharmacokinetic Study of DALBAVANCINE in the Treatment of 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.
Read more
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.
Read the 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
- Being tested
- Pharmacokinetic
- Keywords
- liver transplantation, Biliary complications, DALBAVANCINE, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PharmacokineticOther
Biliary and blood concentration of the DALBAVANCINE
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of biliary diffusion of dalbavancin
Measurement of DALBAVANCIN concentration in bile at Month 2
Measured: At Month 2
Secondary outcomes (7)
Description of the proportion of patients showing good clinical progress 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).
Measured: at Month 2 and Month 6
Description of the proportion of patients showing good biological progress 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.
Measured: at Month 2 and Month 6
Description of the proportion of patients showing good morphological progress 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.
Measured: at Month 2 and Month 6
Record the occurrence of serious adverse events to evaluate the tolerance of the antibiotic therapy.
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.
Measured: 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.
Measurement of DALBAVANCIN concentration, which must be greater than 10 times the MIC to be considered effective.
Measured: at Month 2
Evaluation of the biliary concentration of DALBAVANCIN in comparison with the plasma concentration.
Calculation of the ratio between biliary and plasma concentrations of DALBAVANCIN
Measured: at Month 2 and Month 4
Evaluation of the effectiveness of DALBAVANCIN antibiotic treatment at Month 2 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.
Measured: at Month2 and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Sep 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Salomé GALLET, MD, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601244
- Sponsor's protocol ID
- 38RC24.0165
- Acronym
- DALBATRANS
- Status last verified
- Sep 2024
- First submitted
- 9 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of DALBAVANCINE in the Treatment of Biliary Complications During Liver Transplantation
- ClinicalTrials.gov ID
- NCT06601244
- Acronym / sponsor ID
- DALBATRANS / 38RC24.0165
- Conditions
- Liver Transplantation
- Keywords
- liver transplantation, Biliary complications, DALBAVANCINE, Pharmacokinetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PharmacokineticBiliary and blood concentration of the DALBAVANCINE | Other | – |
Primary outcome
Description of biliary diffusion of dalbavancin
Time frame: At Month 2
Measurement of DALBAVANCIN concentration in bile at Month 2
7 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Related trials for Liver Transplantation
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
Liver Transplant
RecruitingObservational study
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salomé GALLET, MD principal investigator
CHU Grenoble Alpes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Salomé GALLET, MD (0476765291, sgallet@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of biliary diffusion of dalbavancin (time frame: At Month 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.