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

NCT ID: NCT04173286

Last Updated: 2019-11-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-07
• Study Completion Date: 2021-01-01

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).

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.

Conditions

Acute Cholangitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

short term antibiotics

\< 7 days

antibiotherapy

Intervention Type: PROCEDURE

\< 7 days

long terms antibiotics

\> 7 days

antibiotherapy

Intervention Type: PROCEDURE

\< 7 days

Interventions

antibiotherapy

\< 7 days

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital of Nantes

Nantes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Garret Charlotte, MD

Role: CONTACT

charlotte.garret@chu-nantes.fr

0240084737

Facility Contacts

Charlotte Garret

Role: primary

charlotte.garret@chu-nantes.fr

02 40 08 73 75

Other Identifiers

RC19_0423

Identifier Type: -

Identifier Source: org_study_id