Comparisons of Intravenous Ceftriaxone With Intravenous Moxifloxacin in ERCP

Phase 2

Completed

• Conditions: Cholangitis
• Interventions: Drug: ceftriaxone; Drug: Moxifloxacin

• Registration Number: NCT02098486
• Lead Sponsor: Kangbuk Samsung Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-22
• Study First Submitted QC: 2014-03-25
• Study First Posted: 2014-03-28
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-22
• Last Update Posted: 2016-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ceftraxone	ceftriaxone	ceftriaxone (2 g/day, diluted in 40 cc of 5% dextrose water, infused more than 30 min)
Moxifloxacin	Moxifloxacin	Intravenous moxifloxacin (400 mg/day, infused more than 60 min)

Primary Outcome Measures

Name	Time	Method
cholangitis	3 days	To compare the occurrence rate of cholangitis between the intravenous moxifloxacin and ceftriaxone group

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sungkyunkwan University Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of