NCT02098486

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 28, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

1.5 years

First QC Date

March 22, 2014

Last Update Submit

February 22, 2016

Conditions

Cholangitis

Keywords

Bile duct obstructionCholangitisMoxifloxacinCeftriaxoneSepsis

Outcome Measures

Primary Outcomes (1)

  • cholangitis

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

    3 days

Secondary Outcomes (1)

  • 30 day mortality

    30 days

Study Arms (2)

Ceftraxone

ACTIVE COMPARATOR

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

Drug: ceftriaxone

Moxifloxacin

ACTIVE COMPARATOR

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

Drug: Moxifloxacin

Interventions

MoxifloxacinDRUG
Moxifloxacin
ceftriaxoneDRUG
Ceftraxone

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with bile duct obstruction due to variable causes (bile duct stones, benign or malignant stricture, etc)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sungkyunkwan University Kangbuk Samsung Hospital

Seoul, 110-746, South Korea

Location

MeSH Terms

Conditions

CholangitisCholestasisSepsis

Interventions

MoxifloxacinCeftriaxone

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCefotaximeCephacetrileCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur Compounds

Study Officials

  • Hong Joo Kim, MD

    Sungkyunkwan University Kangbuk Samsung Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 22, 2014

First Posted

March 28, 2014

Study Start

March 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

February 24, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)