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// Safety and Efficacy of early switch to oral antibiotic in patients with biliary bacteremia: multicenter, randomized, open label study

Not Applicable
Recruiting
Conditions
Diseases of the digestive system
Registration Number
KCT0000601
Lead Sponsor
Chung-Ang University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
166
Inclusion Criteria

The patients whose age are between 20 and 85, who visited three hospitals including Chung-Ang university hospital since 2010.9, where ciprofloxacin-susceptible gram negative rods were detected on blood stream and receiving biliary decompression due to biliary infection.
Patients were randomized by 1:1 into two groups.

Exclusion Criteria

(1) Absoulute neutrophil count < 500
(2) On applying immunosuppressive agents or having malignancy
(3) Severe infection where BP-intensifing agents or mechanical ventilation would be need
(4) Receiving biliary decompression within 2 weeks
(5) Severe infection in other organs
(6) Other pre-existing hepatobiliary infections or their complications
such as liver abscess
(7) Other additional intravenous antibiotics applied during the study period.
(8) History of cholecystectomy or hepatectomy/lobectomy of liver
(9) study drop-out

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Eradication rate of bacteria at 30-days after diagnosis of bacteremia
Secondary Outcome Measures
NameTimeMethod
Re-infection rate
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