Antibiotic Prophylaxis in Lung-Transplant Recipients

Completed

• Conditions: Lung-transplant Recipients; Antibiotic Prophylaxis

• Registration Number: NCT06760143
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief 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.

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 Timeline

• Study Start: 2024-01-12
• Status Verified: 2024-10
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31
• Study First Submitted: 2024-12-30
• Study First Submitted QC: 2024-12-30
• Study First Posted: 2025-01-06
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 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

Exclusion Criteria

• Lack of clinical and/or laboratory data regarding type of early bacterial infection and/or antibiotic prophylaxis received after lung transplant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnosis of early postoperative infections and/or bacterial donor-derived infections	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

Secondary Outcome Measures

Name	Time	Method
Rectal, urinary and/or respiratory colonization rates by MDRO	Retrospective recruitment period will span from January 2001 to August 2023, with a 60-day retrospective follow-up post-transplant	Rectal, urinary and/or respiratory colonization rates by MDRO within 60 days from transplant
Susceptibility or resistance to piperacillin/tazobactam and/or levofloxacin	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 defined according to each pathogen's breakpoint on MIC values

Trial Locations

Locations (1)

Irccs Aoubo; 🇮🇹 Bologna, Italy