CholangitisPhase 2NCT02098486
Comparisons of Intravenous Ceftriaxone With Intravenous Moxifloxacin in ERCP
A Phase 2 study testing Moxifloxacin and ceftriaxone in people with Cholangitis, run by Kangbuk Samsung Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Cholangitis
- What is being tested?
- Moxifloxacin and ceftriaxone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Sep 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with bile duct obstruction due to variable causes (bile duct stones, benign or malignant stricture, etc)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Sungkyunkwan University Kangbuk Samsung Hospital
Seoul, 110-746
About this study
Official title: Antibiotic Prophylaxis for ERCP: a Comparison of Intravenous Ceftriaxone With Intravenous Moxifloxacin in the Prophylaxis of Cholangitis
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.
- Conditions
- Cholangitis
- Being tested
- Moxifloxacin, ceftriaxone
- Keywords
- Bile duct obstruction, Cholangitis, Moxifloxacin, Ceftriaxone, Sepsis
- Medical subject headings
- Cholangitis, Cholestasis, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxifloxacinDrug
ceftriaxoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Ceftraxone | Active comparator | ceftriaxone (2 g/day, diluted in 40 cc of 5% dextrose water, infused more than 30 min) Receives: Drug: ceftriaxone |
| Moxifloxacin | Active comparator | Intravenous moxifloxacin (400 mg/day, infused more than 60 min) Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
cholangitis
To compare the occurrence rate of cholangitis between the intravenous moxifloxacin and ceftriaxone group
Measured: 3 days
Secondary outcomes (1)
30 day mortality
To compare the occurrence rate of 30-day mortality between moxifloxacin and ceftriaxone treated group
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Joo Kim, Kangbuk Samsung Hospital
- Investigators
- Hong Joo Kim, MD, Principal investigator, Sungkyunkwan University Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098486
- Sponsor's protocol ID
- ERCPMOXIVSCEF
- Status last verified
- Feb 2016
- First submitted
- 22 Mar 2014
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis for ERCP: a Comparison of Intravenous Ceftriaxone With Intravenous Moxifloxacin in the Prophylaxis of Cholangitis
- ClinicalTrials.gov ID
- NCT02098486
- Acronym / sponsor ID
- ERCPMOXIVSCEF
- Conditions
- Cholangitis
- Keywords
- Bile duct obstruction, Cholangitis, Moxifloxacin, Ceftriaxone, Sepsis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 28 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ceftraxone | Active comparator | Drug: ceftriaxoneceftriaxone (2 g/day, diluted in 40 cc of 5% dextrose water, infused more than 30 min) |
| Moxifloxacin | Active comparator | Drug: MoxifloxacinIntravenous moxifloxacin (400 mg/day, infused more than 60 min) |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with bile duct obstruction due to variable causes (bile duct stones, benign or malignant stricture, etc)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moxifloxacin | Drug | Moxifloxacin |
| ceftriaxone | Drug | Ceftraxone |
Primary outcome
cholangitis
Time frame: 3 days
To compare the occurrence rate of cholangitis between the intravenous moxifloxacin and ceftriaxone group
1 secondary outcome
30 day mortality
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
- Individual participant dataSharing planned: No
Related trials for Cholangitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Joo Kim, MD principal investigator
Sungkyunkwan University Kangbuk Samsung Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Moxifloxacin and ceftriaxone in people with Cholangitis, run by Kangbuk Samsung Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cholangitis (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2016; AzTrials last refreshed its copy on 8 Nov 2026.