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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

Page last updated: August 23, 2015

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