Duration of antibiotic therapy in patients with moderate or severe cholangitis

Phase 3

Completed

• Conditions: Health Condition 1: K830- Cholangitis

• Registration Number: CTRI/2021/05/033535
• Lead Sponsor: ot applicable

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-06-10
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

1. Patients with age18 years or older.

2. Patients diagnosed as having moderate to severe acute cholangitis according to Tokyo guidelines 2018.

3. Patients underwent successful biliary drainage via procedures like ERCP, EUS-guided drainage and PTBD.

Exclusion Criteria

1. The patients not willing to participate in the study.

2. When incomplete biliary drainage is suspected (Patient with primary sclerosing cholangitis or portal cavernoma cholangiopathy with multiple intrahepatic biliary stricture or complex hilar stricture like Bismuth type III or IV).

3. Moribund patient like patients requiring ventilatory support or patients with Glasgow coma scale of less 8.

4. Patients with associated or cholangitis related complication which requires longer antibiotics (like liver abscess, acute cholecystitis or metastatic complications like infective endocarditis, pneumonia or septic arthritis at the time of diagnosis).

6. Immunocompromised patients like patients who receiving cancer chemotherapy, steroids (Prednisolone >10mg/d), or immunosuppressive agents.

7. Blood or bile culture grew fungus.

8.Patients with concomitant acute pancreatitis and other infections elsewhere in the body which requires longer hospitalization and/or antibiotics.

9. Pregnant females.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical cure at 30 days after successful biliary drainage. <br/ ><br>(Clinical cure will be defined as absence of recurrence of cholangitis at day 30 and more than 50% reduction of bilirubin compared to initial level at week 2)Timepoint: Day 30

Secondary Outcome Measures

Name	Time	Method
Adverse events due to antibiotics including antibiotic associated diarrhea, Clostridium difficile infection.Timepoint: Day 30;All-cause mortality at day 30 after the successful biliary drainageTimepoint: Day 30;Total days of antibiotics required in both the arms till 30 days after successful biliary drainage <br/ ><br>Timepoint: Day 30;Total days of hospitalization required in both the arms till 30 days after successful biliary drainageTimepoint: Day 30