Antibiotic Prophylaxis in Lung-Transplant Recipients

NCT06760143 | Completed

• 1 other identifier: PRO-LUNG
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung-transplant Recipients; Antibiotic Prophylaxis

Keywords

Lung-Transplant Recipients; piperacillin/tazobactam; levofloxacin; bacterial infections; Multi Drug Resistant Organisms

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  Retrospective recruitment period will span from January 2001 to August 2023, with a 60-day retrospective follow-up post-transplant

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Irccs Aoubo

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Renato Pascale, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 6, 2025
• Study Start: January 12, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: January 10, 2025

Record last verified: 2024-10

Locations

IT (1)