Lung-transplant RecipientsPRO-LUNGNCT06760143
Antibiotic Prophylaxis in Lung-Transplant Recipients
An observational study of Lung-transplant Recipients and Antibiotic Prophylaxis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Retrospective, monocentric observational pharmacological cohort study including all adult patients who underwent lung transplantation at IRCCS Azienda Ospedaliero-Universitaria di Bologna from 1st January 2002 to 31st August 2023. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung-transplant Recipients, Antibiotic Prophylaxis
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jan 2024to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: All adult (≥ 18 years) patients who underwent Lung Transplant (LT) and received peri-operative antibiotic prophylaxis during the study period will be screened for inclusion. Patients are enrolled during follow-up visits within 5 months from the start of the study.
Who may be able to join
- Adult (age ≥ 18 years)
- Patients who underwent LT at IRCCS Azienda Ospedaliero-Universitaria di Bologna from 1st January 2002 to 31st August 2023
- Patients receiving peri-operative antibiotic prophylaxis according to internal guidelines at time of LT
- Signed informed consent
Who cannot join
- Lack of clinical and/or laboratory data regarding type of early bacterial infection and/or antibiotic prophylaxis received after lung transplant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antibiotic Prophylaxis in Lung-Transplant Recipients: a Retrospective Cohort Study
Retrospective, monocentric observational pharmacological cohort study including all adult patients who underwent lung transplantation at IRCCS Azienda Ospedaliero-Universitaria di Bologna from 1st January 2002 to 31st August 2023.
Read the detailed description
Bacterial infections are clinically relevant complications in lung transplant recipients (LTRs) causing chronic lung allograft dysfunction and high rates of mortality, especially within the first year after transplant. Microorganisms responsible for infection can derive from the donor lung or pre-existing recipient flora. Indeed, even though native lungs are removed, colonization of the grafts from recipients colonizing strains often rapidly occurs.
Furthermore, grafts and preservation fluids are frequently infected or colonized with bacteria with a high transmissibility rate to LTRs.
The interpretation of bacterial growth from grafts and preservation fluids can be complex. While some experts recommend against using lungs that show growth of gram-negative bacteria, others permit their use if accompanied by targeted antibiotic therapy, citing retrospective studies that suggest similar overall survival rates for recipients of infected versus uninfected lungs. To prevent donor-derived infections, routine antibiotic prophylaxis is used. International guidelines recommendations are generic and predominantly based on cardiac procedures and no formal recommendations to guide antimicrobial selection in lung transplant (LT) surgery are currently available. Therefore, antibiotic regimens for perioperative prophylaxis are based on clinical judgment and knowledge of the local epidemiology, inducing heterogeneity in clinical practice between centers. In our Center, for the last 20 years, piperacillin/tazobactam plus levofloxacin has been the backbone of the antibiotic prophylaxis regimen for LTRs, according to internal guidelines.
This retrospective observational study aims to investigate the efficacy of piperacillin/tazobactam plus levofloxacin compared to piperacillin/tazobactam alone as antibiotic prophylactic regimens on preventing early bacterial infections and donor derived infection after LT and their possible impact on subsequent colonization by MDR organisms (MDRO). With the study, it will be possible to evaluate which of the two analyzed regimens is associated with a better outcome in the LTR cohort in terms of preventing early surgical site infections, covering the susceptibility of isolates from donor cultures, and influencing MDRO colonization. In this way, it will be possible to influence clinical practice in the center, improving the prognosis of patients undergoing LT. Finally, the data obtained from this study will contribute to increase the knowledge on prophylaxis regimens that can be adopted in hospitals with a similar epidemiological scenario.
- Conditions
- Lung-transplant Recipients, Antibiotic Prophylaxis
- Keywords
- Lung-Transplant Recipients, piperacillin/tazobactam, levofloxacin, bacterial infections, Multi Drug Resistant Organisms
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients underwent Lung Transplant (LT) and received peri-operative antibiotic prophylaxis | All adult (≥ 18 years) patients who underwent Lung Transplant (LT) and received peri-operative antibiotic prophylaxis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of early postoperative infections and/or bacterial donor-derived infections
Diagnosis of early postoperative infections and/or donor-derived bacterial infections acquired within 15 days of lung transplantation. This is expressed as a four-group composite endpoint: no infection, early postoperative infections only, donor-derived bacterial infections only, both early postoperative and donor-derived bacterial infections
Measured: Retrospective recruitment period will span from January 2001 to August 2023, with a 60-day retrospective follow-up post-transplant
Secondary outcomes (2)
Rectal, urinary and/or respiratory colonization rates by MDRO
Rectal, urinary and/or respiratory colonization rates by MDRO within 60 days from transplant
Measured: Retrospective recruitment period will span from January 2001 to August 2023, with a 60-day retrospective follow-up post-transplant
Susceptibility or resistance to piperacillin/tazobactam and/or levofloxacin
Susceptibility or resistance to piperacillin/tazobactam and/or levofloxacin defined according to each pathogen's breakpoint on MIC values
Measured: Retrospective recruitment period will span from January 2001 to August 2023, with a 60-day retrospective follow-up post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start12 Jan 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung-transplant RecipientsStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renato Pascale, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760143
- Sponsor's protocol ID
- PRO-LUNG
- Acronym
- PRO-LUNG
- Status last verified
- Oct 2024
- First submitted
- 30 Dec 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis in Lung-Transplant Recipients: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06760143
- Acronym / sponsor ID
- PRO-LUNG / PRO-LUNG
- Conditions
- Lung-transplant Recipients, Antibiotic Prophylaxis
- Keywords
- Lung-Transplant Recipients, piperacillin/tazobactam, levofloxacin, bacterial infections, Multi Drug Resistant Organisms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective, monocentric observational pharmacological cohort study including all adult patients who underwent lung transplantation at IRCCS Azienda Ospedaliero-Universitaria di Bologna from 1st January 2002 to 31st August 2023.
Detailed description
Bacterial infections are clinically relevant complications in lung transplant recipients (LTRs) causing chronic lung allograft dysfunction and high rates of mortality, especially within the first year after transplant. Microorganisms responsible for infection can derive from the donor lung or pre-existing recipient flora. Indeed, even though native lungs are removed, colonization of the grafts from recipients colonizing strains often rapidly occurs.
Furthermore, grafts and preservation fluids are frequently infected or colonized with bacteria with a high transmissibility rate to LTRs.
The interpretation of bacterial growth from grafts and preservation fluids can be complex. While some experts recommend against using lungs that show growth of gram-negative bacteria, others permit their use if accompanied by targeted antibiotic therapy, citing retrospective studies that suggest similar overall survival rates for recipients of infected versus uninfected lungs. To prevent donor-derived infections, routine antibiotic prophylaxis is used. International guidelines recommendations are generic and predominantly based on cardiac procedures and no formal recommendations to guide antimicrobial selection in lung transplant (LT) surgery are currently available. Therefore, antibiotic regimens for perioperative prophylaxis are based on clinical judgment and knowledge of the local epidemiology, inducing heterogeneity in clinical practice between centers. In our Center, for the last 20 years, piperacillin/tazobactam plus levofloxacin has been the backbone of the antibiotic prophylaxis regimen for LTRs, according to internal guidelines.
This retrospective observational study aims to investigate the efficacy of piperacillin/tazobactam plus levofloxacin compared to piperacillin/tazobactam alone as antibiotic prophylactic regimens on preventing early bacterial infections and donor derived infection after LT and their possible impact on subsequent colonization by MDR organisms (MDRO). With the study, it will be possible to evaluate which of the two analyzed regimens is associated with a better outcome in the LTR cohort in terms of preventing early surgical site infections, covering the susceptibility of isolates from donor cultures, and influencing MDRO colonization. In this way, it will be possible to influence clinical practice in the center, improving the prognosis of patients undergoing LT. Finally, the data obtained from this study will contribute to increase the knowledge on prophylaxis regimens that can be adopted in hospitals with a similar epidemiological scenario.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients underwent Lung Transplant (LT) and received peri-operative antibiotic prophylaxis | – | –All adult (≥ 18 years) patients who underwent Lung Transplant (LT) and received peri-operative antibiotic prophylaxis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult (≥ 18 years) patients who underwent Lung Transplant (LT) and received peri-operative antibiotic prophylaxis during the study period will be screened for inclusion. Patients are enrolled during follow-up visits within 5 months from the start of the study.
Key inclusion criteria (4 listed)
- Adult (age ≥ 18 years)
- Patients who underwent LT at IRCCS Azienda Ospedaliero-Universitaria di Bologna from 1st January 2002 to 31st August 2023
- Patients receiving peri-operative antibiotic prophylaxis according to internal guidelines at time of LT
- Signed informed consent
Key exclusion criteria (1 listed)
- Lack of clinical and/or laboratory data regarding type of early bacterial infection and/or antibiotic prophylaxis received after lung transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis of early postoperative infections and/or bacterial donor-derived infections
Time frame: Retrospective recruitment period will span from January 2001 to August 2023, with a 60-day retrospective follow-up post-transplant
Diagnosis of early postoperative infections and/or donor-derived bacterial infections acquired within 15 days of lung transplantation. This is expressed as a four-group composite endpoint: no infection, early postoperative infections only, donor-derived bacterial infections only, both early postoperative and donor-derived bacterial infections
2 secondary outcomes
Rectal, urinary and/or respiratory colonization rates by MDRO
Time frame: Retrospective recruitment period will span from January 2001 to August 2023, with a 60-day retrospective follow-up post-transplant
Susceptibility or resistance to piperacillin/tazobactam and/or levofloxacin
Time frame: Retrospective recruitment period will span from January 2001 to August 2023, with a 60-day retrospective follow-up post-transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
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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.
Renato Pascale, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung-transplant Recipients and Antibiotic Prophylaxis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 1 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 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnosis of early postoperative infections and/or bacterial donor-derived infections (time frame: Retrospective recruitment period will span from January 2001 to August 2023, with a 60-day retrospective follow-up post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2025.