Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06601244
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
Pharmacokinetic Study in the Biliary Complications During Liver Transplantation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pharmacokinetic Study of DALBAVANCINE in the Treatment of Biliary Complications During Liver Transplantation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DALBATRANS
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None