Liver TransplantationPhase 3NCT02717273
Surgical Site Infections After Liver Transplantation Based on Perioperative Antibiotics
A Phase 3 study testing standard, extended and liver transplant in people with Liver Transplantation and Surgical Site Infection, run by University of Virginia.
Trial summary
This study will be to prospectively determine differences in Surgical Site Infection (SSI) if a prolonged course of post-operative antibiotics are used following liver transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation, Surgical Site Infection
- What is being tested?
- standard, extended and liver transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Oct 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients ≥ 18 years of age.
- Eligible for liver transplantation by UVA standard protocol.
- First-time transplantation.
- No active infections - requiring antibiotics - excluding antifungals.
Who cannot join
- All patients < 18 years of age.
- Previous liver transplantation.
- Active infections - requiring antibiotics.
- Allergy to all standard peri-operative antibiotics (piperacillin/tazobactam or UVA standard alternatives for Penicillin allergic patients: ciprofloxacin and vancomycin).
About this study
Official title: A Randomized, Prospective Study of Surgical Site Infections in Liver Transplant Patients Receiving Three Days of Peri-operative Antibiotic Prophylaxis Versus Intra-operative Antibiotics Only
This study will be to prospectively determine differences in Surgical Site Infection (SSI) if a prolonged course of post-operative antibiotics are used following liver transplantation.
Read the detailed description
This study will be to prospectively determine differences in SSI if a prolonged course of post-operative antibiotics are used following liver transplantation. All adult patients, admitted to the University of Virginia (UVA) Medical Center for first-time liver transplantation will be randomized to the standard of care of peri-operative antibiotics or extended course of three total days.
Patients will be evaluated primarily for the presence of post-operative surgical site infections but also for fever, elevated white blood counts, secondary infections (urinary tract, pneumonia, and blood stream), length of hospital stay, graft loss, and mortality for 30 days after liver transplant.
- Conditions
- Liver Transplantation, Surgical Site Infection
- Being tested
- standard, extended, liver transplant
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardDrug
Also called Peri-operative only antibiotics
peri-operative antibiotic regimen only
extendedDrug
Also called Extended, three-day antibiotics
extended three-day course of antibiotics
liver transplantOther
orthotopic liver transplantation
| Study group | Role | What they receive |
|---|---|---|
| standard peri-operative antibiotics | Active comparator | The standard of care at the University of Virginia Medical Center for liver transplantation patients is a 3.375 gram dose of piperacillin / tazobactam (Zosyn®) at the time of induction of anesthesia, though this dose may be adjusted for renal insufficiency. This dose is repeated during the operation every six hours. Receives: Drug: standard; Other: liver transplant |
| extended three-day course of antibiotics | Experimental | For those patients randomized to the study group, antibiotics will be started as per the usual intra-operative dosing regimen, then continued to provide coverage for 72 hours.
This is typically provided as additional doses of 3.375 grams of piperacillin / tazobactam (Zosyn®) every 8 hours for 3 total days (giving a total of 72 hours of antibiotic coverage), though this may be altered based on kidney function. Receives: Drug: extended; Other: liver transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Development of Surgical Site Infections
development of surgical site infection, including superficial and deep incisional and organ space surgical site infections
Measured: within 30 days from surgery
Secondary outcomes (6)
Number of Subjects With Post-operative Fever
fever above 38.5 degrees Celsius 24 hours after the end of the liver transplant
Measured: 24 hours from surgery
Number of Subjects With Elevated White Blood Count (WBC)
above 15,000 within 24hours after the end of the liver transplant
Measured: 24 hours from surgery
Number of Subjects With Nosocomial Infection
diagnosis of any new infection other than an SSI within 30 days from surgery
Measured: within 30 days from surgery
Length of Hospital Stay
days hospitalized after liver transplant
Measured: within 30 days from surgery
Number of Subjects With Graft Loss
complete loss of liver function in recipient
Measured: within 30 days from surgery
Number of Subjects With Mortality
death within 30 days of liver transplant
Measured: within 30 days from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startMar 2009
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Sawyer, MD, University of Virginia
- Investigators
- Robert G Sawyer, MD, Principal investigator, UVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717273
- Sponsor's protocol ID
- IRB-HSR#14971
- Other IDs
- T32AI078875
- Status last verified
- Jun 2018
- First submitted
- 2 Mar 2016
- Last updated
- 17 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Chan S, Ng S, Chan HP, Pascoe EM, Playford EG, Wong G, Chapman JR, Lim WH, Francis RS, Isbel NM, Campbell SB, Hawley CM, Johnson DW. Perioperative antibiotics for preventing post-surgical site infections in solid organ transplant recipients. Cochrane Database Syst Rev. 2020 Aug 4;8(8):CD013209. doi: 10.1002/14651858.CD013209.pub2.
PubMed 32799356
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective Study of Surgical Site Infections in Liver Transplant Patients Receiving Three Days of Peri-operative Antibiotic Prophylaxis Versus Intra-operative Antibiotics Only
- ClinicalTrials.gov ID
- NCT02717273
- Acronym / sponsor ID
- IRB-HSR#14971
- Conditions
- Liver Transplantation, Surgical Site Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Mar 2009
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 23 Mar 2016 (estimated)
- Results
- Posted 17 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be to prospectively determine differences in Surgical Site Infection (SSI) if a prolonged course of post-operative antibiotics are used following liver transplantation.
Detailed description
This study will be to prospectively determine differences in SSI if a prolonged course of post-operative antibiotics are used following liver transplantation. All adult patients, admitted to the University of Virginia (UVA) Medical Center for first-time liver transplantation will be randomized to the standard of care of peri-operative antibiotics or extended course of three total days.
Patients will be evaluated primarily for the presence of post-operative surgical site infections but also for fever, elevated white blood counts, secondary infections (urinary tract, pneumonia, and blood stream), length of hospital stay, graft loss, and mortality for 30 days after liver transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard peri-operative antibiotics | Active comparator | Drug: standard, Other: liver transplantThe standard of care at the University of Virginia Medical Center for liver transplantation patients is a 3.375 gram dose of piperacillin / tazobactam (Zosyn®) at the time of induction of anesthesia, though this dose may be adjusted for renal insufficiency. This dose is repeated during the operation every six hours. |
| extended three-day course of antibiotics | Experimental | Drug: extended, Other: liver transplantFor those patients randomized to the study group, antibiotics will be started as per the usual intra-operative dosing regimen, then continued to provide coverage for 72 hours. This is typically provided as additional doses of 3.375 grams of piperacillin / tazobactam (Zosyn®) every 8 hours for 3 total days (giving a total of 72 hours of antibiotic coverage), though this may be altered based on kidney function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients ≥ 18 years of age.
- Eligible for liver transplantation by UVA standard protocol.
- First-time transplantation.
- No active infections - requiring antibiotics - excluding antifungals.
Key exclusion criteria (4 listed)
- All patients < 18 years of age.
- Previous liver transplantation.
- Active infections - requiring antibiotics.
- Allergy to all standard peri-operative antibiotics (piperacillin/tazobactam or UVA standard alternatives for Penicillin allergic patients: ciprofloxacin and vancomycin).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standardAlso: Peri-operative only antibioticsperi-operative antibiotic regimen only | Drug | standard peri-operative antibiotics |
| extendedAlso: Extended, three-day antibioticsextended three-day course of antibiotics | Drug | extended three-day course of antibiotics |
| liver transplantorthotopic liver transplantation | Other | extended three-day course of antibiotics, standard peri-operative antibiotics |
Primary outcome
Number of Subjects With Development of Surgical Site Infections
Time frame: within 30 days from surgery
development of surgical site infection, including superficial and deep incisional and organ space surgical site infections
6 secondary outcomes
Number of Subjects With Post-operative Fever
Time frame: 24 hours from surgery
Number of Subjects With Elevated White Blood Count (WBC)
Time frame: 24 hours from surgery
Number of Subjects With Nosocomial Infection
Time frame: within 30 days from surgery
Length of Hospital Stay
Time frame: within 30 days from surgery
Number of Subjects With Graft Loss
Time frame: within 30 days from surgery
Number of Subjects With Mortality
Time frame: within 30 days from surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32799356Chan S, Ng S, Chan HP, Pascoe EM, Playford EG, Wong G, Chapman JR, Lim WH, Francis RS, Isbel NM, Campbell SB, Hawley CM, Johnson DW. Perioperative antibiotics for preventing post-surgical site infections in solid organ transplant recipients. Cochrane Database Syst Rev. 2020 Aug 4;8(8):CD013209. doi: 10.1002/14651858.CD013209.pub2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert G Sawyer, MD principal investigator
UVA
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing standard, extended and liver transplant in people with Liver Transplantation and Surgical Site Infection, run by University of Virginia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Development of Surgical Site Infections (time frame: within 30 days from surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02717273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.