Comparisons of Intravenous Ceftriaxone With Intravenous Moxifloxacin in ERCP
Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Kangbuk Samsung Hospital
Treatments:
Ceftriaxone Fluoroquinolones Moxifloxacin Norgestimate, ethinyl estradiol drug combination