Trial Outcomes & Findings for eXtended Antibiotic Prophylaxis for Intermediate- and High-risk Glands After Pancreatoduodenectomy to Reduce CR-POPF (NCT NCT05753735)
NCT ID: NCT05753735
Last Updated: 2024-09-24
Results Overview
To demonstrate that extended antibiotic prophylaxis in patients with intermediate/high fistula risk score who undergo PD reduces the rate of clinically relevant postoperative pancreatic fistula in the intervention group.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
56 days
Results posted on
2024-09-24
Participant Flow
Participant milestones
| Measure |
Standard Perioperative Antibiotics
The control group will be treated according to current standard perioperative antibiotic practice, and perioperative antibiotics will not exceed 24 hours postoperatively.
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
|
Extended Antibiotic Prophylaxis
The intervention group will receive an extended duration of current standard perioperative antibiotics, then converted to amoxicillin/clavulanic at discharge
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
Amoxicillin/ Clavulanic acid: Amoxicillin/ Clavulanic acid 875/125 mg every 12 hours after discharge to complete 10 days total antibiotics
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
3
|
|
Overall Study
COMPLETED
|
0
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
eXtended Antibiotic Prophylaxis for Intermediate- and High-risk Glands After Pancreatoduodenectomy to Reduce CR-POPF
Baseline characteristics by cohort
| Measure |
Standard Perioperative Antibiotics
The control group will be treated according to current standard perioperative antibiotic practice, and perioperative antibiotics will not exceed 24 hours postoperatively.
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
|
Extended Antibiotic Prophylaxis
n=3 Participants
The intervention group will receive an extended duration of current standard perioperative antibiotics, then converted to amoxicillin/clavulanic at discharge
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
Amoxicillin/ Clavulanic acid: Amoxicillin/ Clavulanic acid 875/125 mg every 12 hours after discharge to complete 10 days total antibiotics
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
—
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
—
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
—
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
—
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 56 daysPopulation: Zero participants were randomized to the standard perioperative antibiotic arm.
To demonstrate that extended antibiotic prophylaxis in patients with intermediate/high fistula risk score who undergo PD reduces the rate of clinically relevant postoperative pancreatic fistula in the intervention group.
Outcome measures
| Measure |
Extended Antibiotic Prophylaxis
n=3 Participants
The intervention group will receive an extended duration of current standard perioperative antibiotics, then converted to amoxicillin/clavulanic at discharge
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
Amoxicillin/ Clavulanic acid: Amoxicillin/ Clavulanic acid 875/125 mg every 12 hours after discharge to complete 10 days total antibiotics
|
Standard Perioperative Antibiotics
The control group will be treated according to current standard perioperative antibiotic practice, and perioperative antibiotics will not exceed 24 hours postoperatively.
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
|
|---|---|---|
|
Clinically Relevant (Grade B/C) Postoperative Pancreatic Fistula Rate
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: At 30 daysPopulation: Zero participants were randomized to the standard perioperative antibiotic arm.
Rate of mortality
Outcome measures
| Measure |
Extended Antibiotic Prophylaxis
n=3 Participants
The intervention group will receive an extended duration of current standard perioperative antibiotics, then converted to amoxicillin/clavulanic at discharge
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
Amoxicillin/ Clavulanic acid: Amoxicillin/ Clavulanic acid 875/125 mg every 12 hours after discharge to complete 10 days total antibiotics
|
Standard Perioperative Antibiotics
The control group will be treated according to current standard perioperative antibiotic practice, and perioperative antibiotics will not exceed 24 hours postoperatively.
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
|
|---|---|---|
|
Mortality
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: At 90 daysPopulation: Zero participants were randomized to the standard perioperative antibiotic arm.
Rate of mortality
Outcome measures
| Measure |
Extended Antibiotic Prophylaxis
n=3 Participants
The intervention group will receive an extended duration of current standard perioperative antibiotics, then converted to amoxicillin/clavulanic at discharge
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
Amoxicillin/ Clavulanic acid: Amoxicillin/ Clavulanic acid 875/125 mg every 12 hours after discharge to complete 10 days total antibiotics
|
Standard Perioperative Antibiotics
The control group will be treated according to current standard perioperative antibiotic practice, and perioperative antibiotics will not exceed 24 hours postoperatively.
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
|
|---|---|---|
|
Mortality
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: At 90 daysPopulation: Zero participants were randomized to the standard perioperative antibiotic arm.
Index postoperative length of stay
Outcome measures
| Measure |
Extended Antibiotic Prophylaxis
n=3 Participants
The intervention group will receive an extended duration of current standard perioperative antibiotics, then converted to amoxicillin/clavulanic at discharge
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
Amoxicillin/ Clavulanic acid: Amoxicillin/ Clavulanic acid 875/125 mg every 12 hours after discharge to complete 10 days total antibiotics
|
Standard Perioperative Antibiotics
The control group will be treated according to current standard perioperative antibiotic practice, and perioperative antibiotics will not exceed 24 hours postoperatively.
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
|
|---|---|---|
|
Index Postoperative Length of Stay
|
6.67 Days
Standard Deviation 1.25
|
—
|
SECONDARY outcome
Timeframe: At 90 daysPopulation: Zero participants were randomized to the standard perioperative antibiotic arm.
Composite 90-day length of stay
Outcome measures
| Measure |
Extended Antibiotic Prophylaxis
n=3 Participants
The intervention group will receive an extended duration of current standard perioperative antibiotics, then converted to amoxicillin/clavulanic at discharge
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
Amoxicillin/ Clavulanic acid: Amoxicillin/ Clavulanic acid 875/125 mg every 12 hours after discharge to complete 10 days total antibiotics
|
Standard Perioperative Antibiotics
The control group will be treated according to current standard perioperative antibiotic practice, and perioperative antibiotics will not exceed 24 hours postoperatively.
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
|
|---|---|---|
|
Composite Length of Stay
|
21.33 Days
Standard Deviation 18.37
|
—
|
SECONDARY outcome
Timeframe: At 30 daysPopulation: Zero participants were randomized to the standard perioperative antibiotic arm.
Rate of readmission
Outcome measures
| Measure |
Extended Antibiotic Prophylaxis
n=3 Participants
The intervention group will receive an extended duration of current standard perioperative antibiotics, then converted to amoxicillin/clavulanic at discharge
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
Amoxicillin/ Clavulanic acid: Amoxicillin/ Clavulanic acid 875/125 mg every 12 hours after discharge to complete 10 days total antibiotics
|
Standard Perioperative Antibiotics
The control group will be treated according to current standard perioperative antibiotic practice, and perioperative antibiotics will not exceed 24 hours postoperatively.
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
|
|---|---|---|
|
Readmission
|
3 number of readmissions
|
—
|
SECONDARY outcome
Timeframe: At 90 daysPopulation: Zero participants were randomized to the standard perioperative antibiotic arm.
Rate of readmission
Outcome measures
| Measure |
Extended Antibiotic Prophylaxis
n=3 Participants
The intervention group will receive an extended duration of current standard perioperative antibiotics, then converted to amoxicillin/clavulanic at discharge
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
Amoxicillin/ Clavulanic acid: Amoxicillin/ Clavulanic acid 875/125 mg every 12 hours after discharge to complete 10 days total antibiotics
|
Standard Perioperative Antibiotics
The control group will be treated according to current standard perioperative antibiotic practice, and perioperative antibiotics will not exceed 24 hours postoperatively.
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
|
|---|---|---|
|
Readmission
|
7 number of readmissions
|
—
|
SECONDARY outcome
Timeframe: At 90 daysPopulation: Zero participants were randomized to the standard perioperative antibiotic arm.
Rate of delayed gastric emptying
Outcome measures
| Measure |
Extended Antibiotic Prophylaxis
n=3 Participants
The intervention group will receive an extended duration of current standard perioperative antibiotics, then converted to amoxicillin/clavulanic at discharge
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
Amoxicillin/ Clavulanic acid: Amoxicillin/ Clavulanic acid 875/125 mg every 12 hours after discharge to complete 10 days total antibiotics
|
Standard Perioperative Antibiotics
The control group will be treated according to current standard perioperative antibiotic practice, and perioperative antibiotics will not exceed 24 hours postoperatively.
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
|
|---|---|---|
|
Delayed Gastric Emptying
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: At 90 daysPopulation: Zero participants were randomized to the standard perioperative antibiotic arm.
Rate of image-guided drain placement
Outcome measures
| Measure |
Extended Antibiotic Prophylaxis
n=3 Participants
The intervention group will receive an extended duration of current standard perioperative antibiotics, then converted to amoxicillin/clavulanic at discharge
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
Amoxicillin/ Clavulanic acid: Amoxicillin/ Clavulanic acid 875/125 mg every 12 hours after discharge to complete 10 days total antibiotics
|
Standard Perioperative Antibiotics
The control group will be treated according to current standard perioperative antibiotic practice, and perioperative antibiotics will not exceed 24 hours postoperatively.
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
|
|---|---|---|
|
Image-guided Drain Placement
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: At 90 daysPopulation: Zero participants were randomized to the standard perioperative antibiotic arm.
Presence of postpancreatectomy hemorrhage
Outcome measures
| Measure |
Extended Antibiotic Prophylaxis
n=3 Participants
The intervention group will receive an extended duration of current standard perioperative antibiotics, then converted to amoxicillin/clavulanic at discharge
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
Amoxicillin/ Clavulanic acid: Amoxicillin/ Clavulanic acid 875/125 mg every 12 hours after discharge to complete 10 days total antibiotics
|
Standard Perioperative Antibiotics
The control group will be treated according to current standard perioperative antibiotic practice, and perioperative antibiotics will not exceed 24 hours postoperatively.
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
|
|---|---|---|
|
Postpancreatectomy Hemorrhage
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: At 90 daysPopulation: Zero participants were randomized to the standard perioperative antibiotic arm.
Presence of superficial surgical site infection
Outcome measures
| Measure |
Extended Antibiotic Prophylaxis
n=3 Participants
The intervention group will receive an extended duration of current standard perioperative antibiotics, then converted to amoxicillin/clavulanic at discharge
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
Amoxicillin/ Clavulanic acid: Amoxicillin/ Clavulanic acid 875/125 mg every 12 hours after discharge to complete 10 days total antibiotics
|
Standard Perioperative Antibiotics
The control group will be treated according to current standard perioperative antibiotic practice, and perioperative antibiotics will not exceed 24 hours postoperatively.
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
|
|---|---|---|
|
Superficial Surgical Site Infection
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: At 90 daysPopulation: Zero participants were randomized to the standard perioperative antibiotic arm.
Presence of deep surgical site infections
Outcome measures
| Measure |
Extended Antibiotic Prophylaxis
n=3 Participants
The intervention group will receive an extended duration of current standard perioperative antibiotics, then converted to amoxicillin/clavulanic at discharge
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
Amoxicillin/ Clavulanic acid: Amoxicillin/ Clavulanic acid 875/125 mg every 12 hours after discharge to complete 10 days total antibiotics
|
Standard Perioperative Antibiotics
The control group will be treated according to current standard perioperative antibiotic practice, and perioperative antibiotics will not exceed 24 hours postoperatively.
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
|
|---|---|---|
|
Deep Surgical Site Infections
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: At 90 daysPopulation: Zero participants were randomized to the standard perioperative antibiotic arm.
Presence of deep space infections/intra-abdominal abscess
Outcome measures
| Measure |
Extended Antibiotic Prophylaxis
n=3 Participants
The intervention group will receive an extended duration of current standard perioperative antibiotics, then converted to amoxicillin/clavulanic at discharge
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
Amoxicillin/ Clavulanic acid: Amoxicillin/ Clavulanic acid 875/125 mg every 12 hours after discharge to complete 10 days total antibiotics
|
Standard Perioperative Antibiotics
The control group will be treated according to current standard perioperative antibiotic practice, and perioperative antibiotics will not exceed 24 hours postoperatively.
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
|
|---|---|---|
|
Deep Space Infections/Intra-abdominal Abscess
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: At 90 daysPopulation: Zero participants were randomized to the standard perioperative antibiotic arm.
Rate of additional drain placement
Outcome measures
| Measure |
Extended Antibiotic Prophylaxis
n=3 Participants
The intervention group will receive an extended duration of current standard perioperative antibiotics, then converted to amoxicillin/clavulanic at discharge
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
Amoxicillin/ Clavulanic acid: Amoxicillin/ Clavulanic acid 875/125 mg every 12 hours after discharge to complete 10 days total antibiotics
|
Standard Perioperative Antibiotics
The control group will be treated according to current standard perioperative antibiotic practice, and perioperative antibiotics will not exceed 24 hours postoperatively.
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
|
|---|---|---|
|
Additional Drain Placement
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: At 90 daysPopulation: Zero participants were randomized to the standard perioperative antibiotic arm.
Measuring occurrences of unplanned return to operating room
Outcome measures
| Measure |
Extended Antibiotic Prophylaxis
n=3 Participants
The intervention group will receive an extended duration of current standard perioperative antibiotics, then converted to amoxicillin/clavulanic at discharge
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
Amoxicillin/ Clavulanic acid: Amoxicillin/ Clavulanic acid 875/125 mg every 12 hours after discharge to complete 10 days total antibiotics
|
Standard Perioperative Antibiotics
The control group will be treated according to current standard perioperative antibiotic practice, and perioperative antibiotics will not exceed 24 hours postoperatively.
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
|
|---|---|---|
|
Unplanned Return to Operating Room
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: At 90 daysPopulation: Zero participants were randomized to the standard perioperative antibiotic arm.
Rate of the presence of acute kidney injury
Outcome measures
| Measure |
Extended Antibiotic Prophylaxis
n=3 Participants
The intervention group will receive an extended duration of current standard perioperative antibiotics, then converted to amoxicillin/clavulanic at discharge
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
Amoxicillin/ Clavulanic acid: Amoxicillin/ Clavulanic acid 875/125 mg every 12 hours after discharge to complete 10 days total antibiotics
|
Standard Perioperative Antibiotics
The control group will be treated according to current standard perioperative antibiotic practice, and perioperative antibiotics will not exceed 24 hours postoperatively.
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
|
|---|---|---|
|
Acute Kidney Injury
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: At 90 daysPopulation: Zero participants were randomized to the standard perioperative antibiotic arm.
Rate of the presence of C. difficile colitis
Outcome measures
| Measure |
Extended Antibiotic Prophylaxis
n=3 Participants
The intervention group will receive an extended duration of current standard perioperative antibiotics, then converted to amoxicillin/clavulanic at discharge
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
Amoxicillin/ Clavulanic acid: Amoxicillin/ Clavulanic acid 875/125 mg every 12 hours after discharge to complete 10 days total antibiotics
|
Standard Perioperative Antibiotics
The control group will be treated according to current standard perioperative antibiotic practice, and perioperative antibiotics will not exceed 24 hours postoperatively.
Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days
|
|---|---|---|
|
C. Difficile Colitis
|
0 Participants
|
—
|
Adverse Events
Standard Perioperative Antibiotics
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Extended Antibiotic Prophylaxis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Nikola Anusic, Protocol Study Coordinator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Phone: 216-421-5986
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place