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Is Short Antibiotherapy Duration After Drainage Suitable for Patients Admitted in Intensive Care Medicine With a Severe Acute Cholangitis? (CASCAD)

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ClinicalTrials.gov Identifier: NCT04173286
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Study Description
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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 1.4% to 5.2%. 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).


Condition or disease Intervention/treatment
Acute Cholangitis Procedure: antibiotherapy

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 Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Is Short Antibiotherapy Duration After Drainage Suitable for Patients Admitted in Intensive Care Medicine With a Severe Acute Cholangitis?
Actual Study Start Date : October 7, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
short term antibiotics
< 7 days
 Procedure: antibiotherapy
< 7 days
long terms antibiotics
> 7 days
 Procedure: antibiotherapy
< 7 days


Outcome Measures
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Primary Outcome Measures :
  1. mortality [ Time Frame: day 28 ]
    Comparison of mortality at day 28 between the two group.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Major patient, hospitalized in a MIR with a diagnosis of CA between 2006 and 2019, whatever the etiology, having had a drainage of the bile ducts regardless of the technique used and the initiation of antibiotic therapy.
Criteria

Inclusion Criteria:

Adult patients (age >18 years) with acute cholangitis Admitted in Intensive care units With a successful biliary drainage And treated with antibiotics

Exclusion Criteria:

patients under 18 years unable to receive a drainage or inefficient drainage Patients with a decision to limit care at the admission pregnancy

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04173286


Contacts
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Contact: Garret Charlotte, MD 0240084737 charlotte.garret@chu-nantes.fr

Locations
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France
University Hospital of Nantes Recruiting
Nantes, France, 44000
Contact: Charlotte Garret    02 40 08 73 75    charlotte.garret@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
More Information
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT04173286    
Other Study ID Numbers: RC19_0423
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangitis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases