Comparisons of Intravenous Ceftriaxone With Intravenous Moxifloxacin in ERCP

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Kangbuk Samsung Hospital
Sponsor:
Information provided by (Responsible Party):
Hong Joo Kim, Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier:
NCT02098486
First received: March 22, 2014
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Cholangitis
Drug: Moxifloxacin
Drug: ceftriaxone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Antibiotic Prophylaxis for ERCP: a Comparison of Intravenous Ceftriaxone With Intravenous Moxifloxacin in the Prophylaxis of Cholangitis

Resource links provided by NLM:


Further study details as provided by Kangbuk Samsung Hospital:

Primary Outcome Measures:
  • cholangitis [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    To compare the occurrence rate of cholangitis between the intravenous moxifloxacin and ceftriaxone group


Secondary Outcome Measures:
  • 30 day mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    To compare the occurrence rate of 30-day mortality between moxifloxacin and ceftriaxone treated group


Estimated Enrollment: 160
Study Start Date: April 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ceftraxone
ceftriaxone (2 g/day, diluted in 40 cc of 5% dextrose water, infused more than 30 min)
Drug: ceftriaxone
Active Comparator: Moxifloxacin
Intravenous moxifloxacin (400 mg/day, infused more than 60 min)
Drug: Moxifloxacin

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02098486

Contacts
Contact: Hong Joo Kim, MD +82-2-2001-8556 ringer2003@gmail.com

Sponsors and Collaborators
Kangbuk Samsung Hospital
Investigators
Principal Investigator: Hong Joo Kim, MD Sungkyunkwan University Kangbuk Samsung Hospital
  More Information

No publications provided

Responsible Party: Hong Joo Kim, Associate Professor, Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier: NCT02098486     History of Changes
Other Study ID Numbers: ERCPMOXIVSCEF
Study First Received: March 22, 2014
Last Updated: March 25, 2014
Health Authority: Korea: Ministry of Food and Drug Safety

Keywords provided by Kangbuk Samsung Hospital:
Bile duct obstruction
Cholangitis
Moxifloxacin
Ceftriaxone
Sepsis

Additional relevant MeSH terms:
Cholangitis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Moxifloxacin
Ceftriaxone
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014