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Comparisons of Intravenous Ceftriaxone With Intravenous Moxifloxacin in ERCP

Primary Purpose

Cholangitis

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Moxifloxacin
ceftriaxone
Sponsored by
Kangbuk Samsung Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholangitis focused on measuring Bile duct obstruction, Cholangitis, Moxifloxacin, Ceftriaxone, Sepsis

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with bile duct obstruction due to variable causes (bile duct stones, benign or malignant stricture, etc)

Exclusion Criteria:

  • pregnancy
  • hypersensitivity to moxifloxacin and/or ceftriaxone
  • previous antibiotic exposure or theophyllin derivatives medication within 14 days of admission
  • previous history of epilepsy
  • previous history of endocarditis of valvular heart disease

Sites / Locations

  • Sungkyunkwan University Kangbuk Samsung Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ceftraxone

Moxifloxacin

Arm Description

ceftriaxone (2 g/day, diluted in 40 cc of 5% dextrose water, infused more than 30 min)

Intravenous moxifloxacin (400 mg/day, infused more than 60 min)

Outcomes

Primary Outcome Measures

cholangitis
To compare the occurrence rate of cholangitis between the intravenous moxifloxacin and ceftriaxone group

Secondary Outcome Measures

30 day mortality
To compare the occurrence rate of 30-day mortality between moxifloxacin and ceftriaxone treated group

Full Information

First Posted
March 22, 2014
Last Updated
February 22, 2016
Sponsor
Kangbuk Samsung Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02098486
Brief Title
Comparisons of Intravenous Ceftriaxone With Intravenous Moxifloxacin in ERCP
Official Title
Antibiotic Prophylaxis for ERCP: a Comparison of Intravenous Ceftriaxone With Intravenous Moxifloxacin in the Prophylaxis of Cholangitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kangbuk Samsung Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Background and aims: The use of prophylactic antibiotics before endoscopic retrograde cholangiopancreatography (ERCP) is recommended by all major international gastroenterological societies, especially in the presence of an obstructed biliary system. Their use is intended to decrease or eliminate the incidence of complications following the procedure, namely cholangitis, cholecystitis, septicemia, and pancreatitis. However, there were a few reports concerning the dosage, duration and adopting antibiotics most suitable for this purpose. The aim of this prospective comparative study is to compare the occurrence rate of post-procedural complications, such as cholangitis, bacteremia and septicemia between intravenous moxifloxacin and ceftriaxone for the prophylactic use in patients with bile duct obstruction who will undergo therapeutic ERCP procedure. Methods: In this prospective study, a total of 160 patients (calculated by IBM SPSS Sample Power, version 3.0) with bile duct obstruction due to variable causes (bile duct stones, benign or malignant stricture, etc) will be enrolled and randomly allocated to intravenous moxifloxacin and ceftriaxone group, respectively (using simple randomization program). Intravenous moxifloxacin (400 mg/day, infused more than 60 min) or ceftriaxone (2 g/day, diluted in 40 cc of 5% dextrose water, infused more than 30 min) will be given 90 minutes before ERCP procedure, and will be given to a patient for more than 3 days if the patient develops symptoms and signs of cholangitis or septicemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangitis
Keywords
Bile duct obstruction, Cholangitis, Moxifloxacin, Ceftriaxone, Sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ceftraxone
Arm Type
Active Comparator
Arm Description
ceftriaxone (2 g/day, diluted in 40 cc of 5% dextrose water, infused more than 30 min)
Arm Title
Moxifloxacin
Arm Type
Active Comparator
Arm Description
Intravenous moxifloxacin (400 mg/day, infused more than 60 min)
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin
Intervention Type
Drug
Intervention Name(s)
ceftriaxone
Primary Outcome Measure Information:
Title
cholangitis
Description
To compare the occurrence rate of cholangitis between the intravenous moxifloxacin and ceftriaxone group
Time Frame
3 days
Secondary Outcome Measure Information:
Title
30 day mortality
Description
To compare the occurrence rate of 30-day mortality between moxifloxacin and ceftriaxone treated group
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with bile duct obstruction due to variable causes (bile duct stones, benign or malignant stricture, etc) Exclusion Criteria: pregnancy hypersensitivity to moxifloxacin and/or ceftriaxone previous antibiotic exposure or theophyllin derivatives medication within 14 days of admission previous history of epilepsy previous history of endocarditis of valvular heart disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Joo Kim, MD
Organizational Affiliation
Sungkyunkwan University Kangbuk Samsung Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sungkyunkwan University Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
110-746
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparisons of Intravenous Ceftriaxone With Intravenous Moxifloxacin in ERCP

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