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Comparisons of Intravenous Ceftriaxone With Intravenous Moxifloxacin in ERCP

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02098486
Enrollment
86
Registered
2014-03-28
Start date
2014-03-31
Completion date
2015-09-30
Last updated
2016-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangitis

Keywords

Bile duct obstruction, Cholangitis, Moxifloxacin, Ceftriaxone, Sepsis

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.

Interventions

DRUGMoxifloxacin
DRUGceftriaxone

Sponsors

Kangbuk Samsung Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
cholangitis3 daysTo compare the occurrence rate of cholangitis between the intravenous moxifloxacin and ceftriaxone group

Secondary

MeasureTime frameDescription
30 day mortality30 daysTo compare the occurrence rate of 30-day mortality between moxifloxacin and ceftriaxone treated group

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026