Antibiotics to Decrease Post ERCP Cholangitis
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|ClinicalTrials.gov Identifier: NCT03087656|
Recruitment Status : Recruiting
First Posted : March 22, 2017
Last Update Posted : May 22, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Cholangitis||Drug: Ceftriaxone Drug: Levofloxacin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||subjects to be randomized into two arms: antibiotic arm and no antibiotic arm|
|Official Title:||Randomized Trial of Short Antibiotic Course to Decrease Post ERCP Cholangitis|
|Actual Study Start Date :||March 29, 2017|
|Estimated Primary Completion Date :||February 23, 2021|
|Estimated Study Completion Date :||February 23, 2021|
Active Comparator: Antibiotic arm
The drugs ceftriaxone and levofloxacin will be administered to patients in the antibiotic arm.
Intravenous Ceftriaxone will be given during the procedure.
Other Name: Rocephin
Oral Levofloxacin will be given for 3 days after the procedure.
Other Name: Levaquin
No Intervention: No Antibiotic arm
No prophylactic antibiotics will be administered.
- Proportion of patients who develop Post-ERCP Cholangitis as defined by the revised Tokyo criterion. [ Time Frame: 1 week ]The primary outcome will be the proportion of patients who develop develop post-ERCP cholangitis as defined by the Revised Tokyo criterion within 1 week of ERCP.
- Days of hospitalization [ Time Frame: 1 week ]The number of days of hospitalization following ERCP will be compared among the two groups.
- Proportion of patients who develop adverse events of antibiotics [ Time Frame: 1 week ]The proportion of patients in the two groups who develop allergic reactions, C. difficile colitis, and other adverse symptoms attributable to antibiotic use will be compared.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03087656
|Contact: James Buxbaum||323 409 firstname.lastname@example.org|
|Principal Investigator:||James Buxbaum||University of Southern California Health Science Center|