Comparisons of Intravenous Ceftriaxone With Intravenous Moxifloxacin in ERCP
Information source: Kangbuk Samsung Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cholangitis
Intervention: Moxifloxacin (Drug); ceftriaxone (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: Kangbuk Samsung Hospital Official(s) and/or principal investigator(s):
Hong Joo Kim, MD, Principal Investigator, Affiliation: Sungkyunkwan University Kangbuk Samsung Hospital
Overall contact:
Hong Joo Kim, MD, Phone: +82-2-2001-8556, Email: ringer2003@gmail.com
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.
Clinical Details
Official title: Antibiotic Prophylaxis for ERCP: a Comparison of Intravenous Ceftriaxone With Intravenous Moxifloxacin in the Prophylaxis of Cholangitis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: cholangitis
Secondary outcome: 30 day mortality
Eligibility
Minimum age: 19 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Hong Joo Kim, MD, Phone: +82-2-2001-8556, Email: ringer2003@gmail.com Additional Information
Starting date: April 2014
Last updated: March 25, 2014
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