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

NCT04173286 | Unknown

• 1 other identifier: RC19_0423
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Cholangitis

Outcome Measures

Primary Outcomes (1)

• mortality

  Comparison of mortality at day 28 between the two group.

  day 28

Study Arms (2)

short term antibiotics

\< 7 days

Procedure: antibiotherapy

long terms antibiotics

\> 7 days

Procedure: antibiotherapy

Interventions

antibiotherapy PROCEDURE

\< 7 days

long terms antibiotics; short term antibiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

University Hospital of Nantes

Nantes, 44000, France

RECRUITING

Central Study Contacts

Garret Charlotte, MD

CONTACT

0240084737; charlotte.garret@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 21, 2019
• Study Start: October 7, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2021
• Last Updated: November 21, 2019

Record last verified: 2019-11

Locations

FR (1)