Randomized Trial of Short Antibiotic Course to Decrease Post ERCP Cholangitis

Who is this study for? Adult patients with primary biliary cholangitis
What treatments are being studied? Ceftriaxone+Levofloxacin
Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopic procedure used to treat bile duct stones, obstructive jaundice, biliary leaks, and a variety of other conditions. There is active debate whether antibiotics should be given prophylactically for ERCP outside of high risk indications including primary sclerosing cholangitis. In part this is due to a lack of appropriately powered clinical trials with adequate follow up. The aim will be to assess whether prophylactic antibiotics decrease the rate of post ERCP cholangitis as defined by the Revised Tokyo Criterion.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• Patients aged 18 to 90 years undergoing therapeutic ERCP for standard, biliary indications including but not limited to:

‣ suspected bile duct stones

⁃ malignant and benign biliary obstruction

⁃ bile leaks

Locations
United States
California
Los Angeles County Hospital
RECRUITING
Los Angeles
Contact Information
Primary
James Buxbaum
jbuxbaum@usc.edu
323 409 5371
Time Frame
Start Date: 2017-03-29
Completion Date: 2024-02-23
Participants
Target number of participants: 200
Treatments
Active_comparator: Antibiotic arm
The drugs ceftriaxone and levofloxacin will be administered to patients in the antibiotic arm.
No_intervention: No Antibiotic arm
No prophylactic antibiotics will be administered.
Sponsors
Leads: University of Southern California

This content was sourced from clinicaltrials.gov