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Antibiotic
Extended Antibiotics for Pancreatic Fistula
Phase 2
Recruiting
Led By Lee M. Ocuin, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 90 days
Awards & highlights
Study Summary
This trial will investigate if prolonged antibiotics after pancreatoduodenectomy can prevent pancreatic fistula & its complications. Participants at high risk will take antibiotics through vein & orally.
Who is the study for?
This trial is for adults over 18 who are undergoing pancreatoduodenectomy at UH CMC and can consent to participate. They must have a creatinine clearance above 40 ml/min, indicating good kidney function. People with active infections, allergies to study drugs, concurrent clinical trial participation, or metastatic disease found during surgery are excluded.Check my eligibility
What is being tested?
The trial tests if extended antibiotic use after pancreatoduodenectomy reduces pancreatic fistula risk. High-risk patients will receive Piperacillin/Tazobactam or Amoxicillin/Clavulanic acid intravenously in the hospital and orally post-discharge.See study design
What are the potential side effects?
Possible side effects of the antibiotics may include allergic reactions, gastrointestinal issues like diarrhea or nausea, potential liver enzyme changes, and an increased risk of developing resistance to antibiotics.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinically relevant (Grade B/C) postoperative pancreatic fistula rate
Secondary outcome measures
Acute kidney injury
Additional drain placement
C. difficile colitis
+11 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Extended antibiotic prophylaxisExperimental Treatment2 Interventions
The intervention group will receive an extended duration of current standard perioperative antibiotics, then converted to amoxicillin/clavulanic at discharge
Group II: Standard perioperative antibioticsActive Control1 Intervention
The control group will be treated according to current standard perioperative antibiotic practice, and perioperative antibiotics will not exceed 24 hours postoperatively.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Piperacillin/Tazobactam
2018
Completed Phase 4
~970
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
453 Previous Clinical Trials
31,794 Total Patients Enrolled
Lee M. Ocuin, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My surgery was stopped or changed due to spread of disease during the operation.I am scheduled for a specific pancreas surgery at UH CMC.I am older than 18 years.I can understand and am willing to sign the consent form.I am allergic to certain antibiotics like Piperacillin or Amoxicillin.I had a bad reaction to the usual dose of antibiotic given before surgery.I have an infection that will be treated with antibiotics at the time of surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Standard perioperative antibiotics
- Group 2: Extended antibiotic prophylaxis
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is extended antibiotic prophylaxis a risk-free option for patients?
"According to Power, the safety rating of extended antibiotic prophylaxis is 2 as there are data points that suggest it is safe but not yet any that support its efficacy."
Answered by AI
Are participants being actively sought for this research endeavor?
"According to information from clinicaltrials.gov, this medical study is currently not recruiting participants. Initially posted on June 1st 2023 and last updated February 22nd 2023, it does not have any available spots for enrolment. However, 113 other trials are now open for recruitment."
Answered by AI
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