Comparisons of Intravenous Ceftriaxone With Intravenous Moxifloxacin in ERCP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cholangitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ceftraxone

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

Group Type ACTIVE_COMPARATOR

ceftriaxone

Intervention Type DRUG

Moxifloxacin

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

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

Interventions

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Moxifloxacin

Intervention Type DRUG

ceftriaxone

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No