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OpenTrials
Completed

NCT Number: NCT02098486

Comparisons of Intravenous Ceftriaxone With Intravenous Moxifloxacin in ERCP

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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Key information

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sungkyunkwan University Kangbuk Samsung Hospital

Seoul, 110-746, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

moxifloxacin

Drug

Ceftriaxone

Drug

Primary outcomes

  1. cholangitis

    Time frame: 3 days

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

Secondary outcomes

  1. 30 day mortality

    Time frame: 30 days

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

Sponsors and collaborators

Lead sponsor

Kangbuk Samsung Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 28, 2014
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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