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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0000601

Enrollment

166

Registered

2012-12-10

Start date

2010-10-18

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Conventional treatment for biliary bacteremia with intravenous administration of 3rd generation cephalosporine for at least 10 days will be compared with early oral switch to ciprofloxacin afte

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Eradication rate of bacteria at 30-days after diagnosis of bacteremia	—

Secondary

Measure	Time frame
Re-infection rate	—

Countries

Korea, Republic of

Contacts

Public ContactHyoung-Chul Oh

Chung-Ang University

Outcome results