Ignite Creation Date:
2024-05-06 @ 1:58 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04173286
Status:
UNKNOWN
Last Update Posted:
2019-11-21
First Post:
2019-11-20
Brief Title:
Is Short Antibiotherapy Duration After Drainage Suitable for Patients Admitted in Intensive Care Medicine With a Severe Acute Cholangitis
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Is Short Antibiotherapy Duration After Drainage Suitable for Patients Admitted in Intensive Care Medicine With a Severe Acute Cholangitis
Status:
UNKNOWN
Status Verified Date:
2019-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CASCAD
Brief Summary:
Acute cholangitis AC occurs when biliary stenosis due to various benign causes often gallstones or the presence of a tumour leads to cholestasis and biliary infection AC is a life-threatening infection if not diagnosed and treated in time its mortality ranges from 14 to 52 AC can be classified into different stages of severity depending on organ failure A severity classification has been proposed by the Asian recommendations of Tokyo 2013 Grade I Benin Grade II Moderate and Grade III Severe
AC treatment includes endoscopic or percutaneous bile drainage in combination with systemic antibiotic treatment It is currently recommended that patients with severe CA Grade III have biliary drainage within 24 hours although it has not been shown to improve their survival The emergence of antibiotic-resistant germs which is a public health issue calls for reasonable and considered use of antibiotics Reducing the duration of antibiotic therapy is a fundamental measure of antimicrobial management and antibiotics sparing 7 to 10 days of antibiotic treatment is common in the treatment of CA A 14-day treatment is recommended in case of associated bacteremia A recent study of 263 patients showed that reducing the duration of antibiotic therapy to less than 7 days in patients with CA associated with bacteremia with effective drainage does not increase the risk of recurrence or mortality at 30 days However this study was monocentric retrospective and compared groups that were unbalanced in terms of CA severity The optimal duration of antibiotic therapy in the treatment of CA in critically ill patients hospitalized in intensive care remains poorly known
The main purpose of this study is to compare short antibiotic therapy with long antibiotic therapy in terms of mortality in patients with AC admitted in intensive care unit ICU
AC treatment includes endoscopic or percutaneous bile drainage in combination with systemic antibiotic treatment It is currently recommended that patients with severe CA Grade III have biliary drainage within 24 hours although it has not been shown to improve their survival The emergence of antibiotic-resistant germs which is a public health issue calls for reasonable and considered use of antibiotics Reducing the duration of antibiotic therapy is a fundamental measure of antimicrobial management and antibiotics sparing 7 to 10 days of antibiotic treatment is common in the treatment of CA A 14-day treatment is recommended in case of associated bacteremia A recent study of 263 patients showed that reducing the duration of antibiotic therapy to less than 7 days in patients with CA associated with bacteremia with effective drainage does not increase the risk of recurrence or mortality at 30 days However this study was monocentric retrospective and compared groups that were unbalanced in terms of CA severity The optimal duration of antibiotic therapy in the treatment of CA in critically ill patients hospitalized in intensive care remains poorly known
The main purpose of this study is to compare short antibiotic therapy with long antibiotic therapy in terms of mortality in patients with AC admitted in intensive care unit ICU
Detailed Description:
Using electronic patient data monitoring systems the investigators reviewed all patients with a diagnosis of AC admitted to digestive liver disease unity or ICUs at the Nantes University Hospital Rennes University Hospital from January 1 2006 to december 31 2018 For enrolled patients general clinical characteristics were collected Patients were categorized into two groups according to antibiotics duration and the differences of these characteristics between two groups were evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None