Comparisons of Intravenous Ceftriaxone With Intravenous Moxifloxacin in ERCP

Cholangitis Clinical Trial

Official title:

Antibiotic Prophylaxis for ERCP: a Comparison of Intravenous Ceftriaxone With Intravenous Moxifloxacin in the Prophylaxis of Cholangitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098486
• Other study ID #: ERCPMOXIVSCEF
• Status: Completed
• Phase: Phase 2
• First received: March 22, 2014
• Last updated: February 22, 2016
• Start date: March 2014
• Est. completion date: September 2015

Study information

• Verified date: February 2016
• Source: Kangbuk Samsung Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholangitis

Intervention

Drug:
• Moxifloxacin

• ceftriaxone

Locations

Country	Name	City	State
Korea, Republic of	Sungkyunkwan University Kangbuk Samsung Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cholangitis	To compare the occurrence rate of cholangitis between the intravenous moxifloxacin and ceftriaxone group	3 days	No
Secondary	30 day mortality	To compare the occurrence rate of 30-day mortality between moxifloxacin and ceftriaxone treated group	30 days	No