Trial record 1 of 1 for:
03269994
Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy?
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03269994 |
|
Recruitment Status :
Active, not recruiting
First Posted : September 1, 2017
Last Update Posted : May 23, 2023
|
Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborators:
Indiana University
Massachusetts General Hospital
Thomas Jefferson University
Washington University School of Medicine
Advocate Illinois Masonic Medical Center
Baptist Memorial Health Care Corporation
Baylor Scott and White Health
The Cleveland Clinic
Emory University
Fox Chase Cancer Center
Gundersen Lutheran Medical Center
Hackensack Meridian Health
Hamilton Health Sciences Center
Intermountain Health Care, Inc.
Jersey Shore Medical Center (Hackensack Meridian)
Johns Hopkins University
Montefiore Medical Center/Albert Einstein College of Medicine
North Shore University HealthSystem
Milton S. Hershey Medical Center
Rhode Island Hospital
Stony Brook Medicine
Sunnybrook Health Sciences Centre, Canada
Temple University
The Ohio State University Wexner Medical Center
The Ottowa Hospital/University of Ottowa
University of California, Davis
University of Chicago
University of Iowa
University of Texas Southwestern Medical Center
University of Utah
University of Wisconsin, Madison
Providence Health & Services
Albany Medical College
Northwestern University
Universtiy of Mississippi Medical Center
Mount Sinai Hospital, New York
Brody School of Medicine at East Carolina University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The purpose of this study is to figure out which commonly used antibiotic, cefoxitin or piperacillin-tazobactam, is better at decreasing the rate of surgical site infections after pancreatoduodenectomy.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pancreatic Cancer Pancreas Cancer Pancreatic Diseases | Drug: Cefoxitin Drug: Piperacillin-tazobactam | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 962 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase III Multicenter, Open Label Randomized Controlled Trial of Cefoxitin Versus Piperacillin-Tazobactam as Surgical Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy |
| Actual Study Start Date : | November 21, 2017 |
| Estimated Primary Completion Date : | August 28, 2023 |
| Estimated Study Completion Date : | August 28, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Antibiotics
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Cefoxitin |
Drug: Cefoxitin
Participants will receive one dose of cefoxitin within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time. |
| Experimental: Piperacillin-tazobactam |
Drug: Piperacillin-tazobactam
Participants will receive one dose of piperacillin-tazobactam within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time. |
Primary Outcome Measures :
- Compare the effectiveness of cefoxitin with piperacillin-tazobactam as surgical antibiotic prophylaxis in decreasing the overall rate of postoperative surgical site infections in participants undergoing pancreatoduodenectomy [ Time Frame: 30 days ]To compare the effectiveness of cefoxitin, a second generation cephalosporin (Cohort 1), with piperacillin-tazobactam, a broad-spectrum penicillin (Cohort 2), as surgical antibiotic prophylaxis in decreasing the overall rate of postoperative SSIs in patients undergoing PD. The primary endpoint, overall SSI rate, is defined as superficial incisional SSI, deep incisional SSI, or organ/space SSI within the first 30 days after the operation, as defined according to the ACS NSQIP data collection operations manual.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age >/= 18 years
- Patients undergoing elective pancreatoduodenectomy (PD) for any diagnosis/indication
Exclusion Criteria:
- Patients undergoing a minimally invasive PD, such as laparoscopic or robotic PD
- Patients with known and documented allergies to any of the penicillins, cephalosporins, or β-lactamase inhibitors
- Patients who are otherwise ineligible to receive the antibiotics in this study
- Patients highly unlikely to undergo PD according to the surgeon's judgment, such as conditions amenable to pancreas enucleation, ampullectomy, etc.
- Patients with long-term glucocorticosteroid use. The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular)
- Patients unable to provide informed consent
- Creatinine clearance (CrCl) </= 40 mL/min
- Patients receiving hemodialysis or peritoneal dialysis
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
- Patients with a known bacterial infection present at the time of surgery or who received antimicrobial therapy within 7 days prior to surgery
Information from the National Library of Medicine
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): NCT03269994
Locations
Show 32 study locations
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Indiana University
Massachusetts General Hospital
Thomas Jefferson University
Washington University School of Medicine
Advocate Illinois Masonic Medical Center
Baptist Memorial Health Care Corporation
Baylor Scott and White Health
The Cleveland Clinic
Emory University
Fox Chase Cancer Center
Gundersen Lutheran Medical Center
Hackensack Meridian Health
Hamilton Health Sciences Center
Intermountain Health Care, Inc.
Jersey Shore Medical Center (Hackensack Meridian)
Johns Hopkins University
Montefiore Medical Center/Albert Einstein College of Medicine
North Shore University HealthSystem
Milton S. Hershey Medical Center
Rhode Island Hospital
Stony Brook Medicine
Sunnybrook Health Sciences Centre, Canada
Temple University
The Ohio State University Wexner Medical Center
The Ottowa Hospital/University of Ottowa
University of California, Davis
University of Chicago
University of Iowa
University of Texas Southwestern Medical Center
University of Utah
University of Wisconsin, Madison
Providence Health & Services
Albany Medical College
Northwestern University
Universtiy of Mississippi Medical Center
Mount Sinai Hospital, New York
Brody School of Medicine at East Carolina University
Investigators
| Principal Investigator: | Michael D'Angelica, MD | Memorial Sloan Kettering Cancer Center |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Memorial Sloan Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT03269994 |
| Other Study ID Numbers: |
17-418 |
| First Posted: | September 1, 2017 Key Record Dates |
| Last Update Posted: | May 23, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Memorial Sloan Kettering Cancer Center:
|
pancreatoduodenectomy 17-418 cefoxitin piperacillin-tazobactam |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Pancreatic Diseases Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Endocrine System Diseases Tazobactam |
Piperacillin Piperacillin, Tazobactam Drug Combination Cefoxitin Anti-Bacterial Agents Anti-Infective Agents beta-Lactamase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |