Antibiotic arm for Cholangitis

Los Angeles County Hospital, Los Angeles, CA
CholangitisLevofloxacin - Drug
18 - 90
All Sexes
What conditions do you have?

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.

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 1 week

1 week
Days of hospitalization
Proportion of patients who develop Post-ERCP Cholangitis as defined by the revised Tokyo criterion.
Proportion of patients who develop adverse events of antibiotics

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2 Treatment Groups

Antibiotic arm
1 of 2
No Antibiotic arm
1 of 2

Active Control

200 Total Participants · 2 Treatment Groups

Primary Treatment: Antibiotic arm · No Placebo Group · Phase 4

Antibiotic armActiveComparator Group · 2 Interventions: Levofloxacin, Ceftriaxone · Intervention Types: Drug, Drug
No Antibiotic armNoIntervention Group · 1 Intervention: No Antibiotic arm · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 week

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
850 Previous Clinical Trials
1,433,806 Total Patients Enrolled
2 Trials studying Cholangitis
1,456 Patients Enrolled for Cholangitis
James BuxbaumPrincipal InvestigatorUniversity of Southern California Health Science Center

Eligibility Criteria

Age 18 - 90 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are between the ages of 18 to 90 and are having a procedure called ERCP to treat blockages or other issues in your bile duct.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

How many participants are currently involved in this research endeavor?

"Affirmative. According to, 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.