Recruiting

Prophylactic Antibiotics

Sponsor:

University of Southern California

Code:

NCT03087656

Conditions

Cholangitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ceftriaxone

Levofloxacin

Study Details

Brief 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.

Conditions

Cholangitis

Study ID

NCT03087656

Start date

Mar 29, 2017

Status verified date

Mar, 2023

Completion date

Feb 23, 2024

Anticipated

Primary completion date

Feb 23, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients who are incarcerated
  • Patients who are not competent to give informed consent
  • Patients in whom periprocedural antibiotics are mandatory.
  • These include patients with:

  • primary sclerosing cholangitis,
  • multiple biliary strictures,
  • hilar tumors,
  • neutropenia (absolute neutrophil count <500), or
  • immunosuppressive therapy.
  • Patients who have been diagnosed with cholangitis or are suspected to have another active infection requiring antibiotics (such as an infected fluid collection).
  • Patients who have received antibiotics within 7 days.
  • Patient who have undergone ERCP within 30 days.
  • Patients who undergo multiple ERCP for clinical indication will only be eligible to participate in the study for one procedure.
  • Patients who have had prior biliary surgeries.
  • Patients in whom bile duct decompression is unsuccessful will be excluded as these patients are at increased risk of cholangitis.
  • Patients with immediate procedural complications such as a bowel perforation.
  • Patients undergoing ERCP for diagnostic purposes only will be excluded as the aim is to study the role of antibiotics in those undergoing therapeutic ERCP.
  • Pregnant women
  • Patient with allergies to fluoroquinolones. Patient with allergies to cephalosporins or penicillin's may receive fluoroquinolones if they are randomized to antibiotics arm.
  • Patients with renal insufficiency (creatinine clearance <80ml50ml/minute), in whom dose modifications are necessary.

Withdrawal Criteria:

  • Patients who withdraw consent will be withdrawn from the study.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Ceftriaxone

Intravenous Ceftriaxone will be given during the procedure.

Levofloxacin

Oral Levofloxacin will be given for 3 days after the procedure.

Primary outcome measure

  • Proportion of patients who develop Post-ERCP Cholangitis as defined by the revised Tokyo criterion. [ Time Frame: 1 week ]

Central Contacts and Locations

Central contacts

James Buxbaum

323 409 5371jbuxbaum@usc.edu

Locations

Los Angeles County Hospital

Recruiting

Los Angeles, California, United States, 90033

Contacts

James Buxbaum, MD

323-409-5371jbuxbaum@usc.edu

Jessica Serna, BS

323 409 6939Jessica.Serna@med.usc.edu

More Information

Sponsor

University of Southern California

Last update posted

Mar 6, 2023

Last verified

Mar, 2023

Keywords

  • levofloxacin
  • Ceftriaxone
  • Cholangitis
  • ERCP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Southern California on 2023-03-06.