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Clinical Trials/NCT02098486
NCT02098486
Completed
Phase 2

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

Kangbuk Samsung Hospital1 site in 1 country86 target enrollmentMarch 2014
ConditionsCholangitis

Overview

Phase
Phase 2
Intervention
ceftriaxone
Conditions
Cholangitis
Sponsor
Kangbuk Samsung Hospital
Enrollment
86
Locations
1
Primary Endpoint
cholangitis
Status
Completed
Last Updated
10 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
September 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kangbuk Samsung Hospital
Responsible Party
Principal Investigator
Principal Investigator

Hong Joo Kim

Associate Professor

Kangbuk Samsung Hospital

Eligibility 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

Arms & Interventions

Ceftraxone

ceftriaxone (2 g/day, diluted in 40 cc of 5% dextrose water, infused more than 30 min)

Intervention: ceftriaxone

Moxifloxacin

Intravenous moxifloxacin (400 mg/day, infused more than 60 min)

Intervention: Moxifloxacin

Outcomes

Primary Outcomes

cholangitis

Time Frame: 3 days

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

Secondary Outcomes

  • 30 day mortality(30 days)

Study Sites (1)

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