Comparisons of Intravenous Ceftriaxone With Intravenous Moxifloxacin in ERCP

Study Overview
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Brief Summary
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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.

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

Conditions
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Cholangitis

Intervention / Treatment
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* Drug: Moxifloxacin
* Drug: ceftriaxone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ceftraxone<br>ceftriaxone (2 g/day, diluted in 40 cc of 5% dextrose water, infused more than 30 min) | Drug: ceftriaxone<br> <br> |
| Active Comparator: Moxifloxacin<br>Intravenous moxifloxacin (400 mg/day, infused more than 60 min) | Drug: Moxifloxacin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cholangitis | To compare the occurrence rate of cholangitis between the intravenous moxifloxacin and ceftriaxone group | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 day mortality | To compare the occurrence rate of 30-day mortality between moxifloxacin and ceftriaxone treated group | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bile duct obstruction, Cholangitis, Moxifloxacin, Ceftriaxone, Sepsis