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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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
899 Previous Clinical Trials
1,595,093 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are seniors aged 70 and over being considered for inclusion in this research project?

"Applicants must be between 18-90 years old to qualify for this study, outlined in the conditions of participation."

Answered by AI

Has the FDA sanctioned Antibiotic arm for therapeutic use?

"The safety of the Antibiotic arm has been rated a 3, as it is part of Phase 4 trials which indicates approval."

Answered by AI

Is recruitment for this research still happening?

"This medical experiment has been actively recruiting participants since March 29th 2017 and is still seeking individuals, as evidenced by its most recent update on December 6th 2021."

Answered by AI

How many participants are currently involved in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this experiment was initially posted on March 29th 2017 and is actively seeking participants; the most recent edit occurred December 6th 2021. The research requires 200 people at a single location."

Answered by AI

What bacterial infections most regularly respond to antibiotic treatment?

"Antibiotic arm therapy is regularly utilized to treat abscesses, as well as pyoderma, post-operative infection prevention, and prophylactic defense against neonatal conjunctivitis caused by gonorrhoea."

Answered by AI

What qualifications must prospective participants meet for this clinical trial?

"This clinical trial is interested in recruiting approximately 200 individuals who are afflicted with cholangitis and between 18 to 90 years old."

Answered by AI
Recent research and studies
~25 spots leftby Mar 2025