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Antibiotic

Antibiotics for Cholangitis

Phase 4
Recruiting
Led By James Buxbaum
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Patients who are not competent to give informed consent
Patients with renal insufficiency (creatinine clearance <80ml50ml/minute)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will help researchers understand if giving antibiotics to people before they undergo the ERCP procedure can help prevent cholangitis, a condition where the bile ducts become inflamed.

Who is the study for?
This trial is for adults aged 18 to 90 undergoing therapeutic ERCP for bile duct stones or obstructions, among other indications. Excluded are those with renal insufficiency, mandatory need for antibiotics, certain conditions like primary sclerosing cholangitis or neutropenia, active infections requiring antibiotics, recent ERCP within 30 days, pregnant women, incarcerated individuals and those allergic to the study drugs.
What is being tested?
The trial tests if prophylactic antibiotics (Ceftriaxone or Levofloxacin) can reduce post-ERCP cholangitis rates. It's designed to settle debates on antibiotic use in standard-risk ERCP procedures by comparing outcomes with and without these preventive medications.
What are the potential side effects?
Possible side effects of Ceftriaxone and Levofloxacin may include allergic reactions, gastrointestinal issues like nausea or diarrhea, headache, dizziness and potential risk of tendon damage or inflammation.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to understand and give consent for my treatment.
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My kidney function is reduced.
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I experienced complications like bowel perforation after a recent procedure.
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I have been diagnosed with cholangitis or might have another infection needing antibiotics.
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I have had surgery on my bile ducts before.
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My bile duct decompression was not successful.
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I am having an ERCP for diagnosis only.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of patients who develop Post-ERCP Cholangitis as defined by the revised Tokyo criterion.
Secondary study objectives
Days of hospitalization
Proportion of patients who develop adverse events of antibiotics

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Group I: Antibiotic armActive Control2 Interventions
The drugs ceftriaxone and levofloxacin will be administered to patients in the antibiotic arm.
Group II: No Antibiotic armActive Control1 Intervention
No prophylactic antibiotics will be administered.

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
944 Previous Clinical Trials
1,604,445 Total Patients Enrolled
2 Trials studying Cholangitis
1,456 Patients Enrolled for Cholangitis
James BuxbaumPrincipal InvestigatorUniversity of Southern California Health Science Center

Media Library

Cholangitis Research Study Groups: Antibiotic arm, No Antibiotic arm
~23 spots leftby Nov 2025
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