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Search / Trial NCT06874920

Outcomes of Empiric Antibiotic Therapy Based on Hospital Antibiograms in Organ Transplant Recipients with Bacteraemia

Launched by FONDAZIONE IRCCS CA' GRANDA, OSPEDALE MAGGIORE POLICLINICO · Mar 8, 2025

Trial Information

Current as of November 11, 2025

Enrolling by invitation

Keywords

Hospital Cumulative Antibiogram Solid Organ Transplant Bloodstream Infections

ClinConnect Summary

This study looks at whether using a hospital’s local antibiogram (a chart showing which antibiotics usually work best against bugs found in that hospital) to guide the first antibiotic treatment helps solid organ transplant patients who develop bloodstream infections. Researchers will compare two groups: those whose initial therapy matched a high likelihood of success based on the antibiogram (OAS ≥ 90%) and those whose initial therapy did not (OAS < 90%). The main question is whether this approach reduces deaths 15 days after the bloodstream infection. They’ll also look at other outcomes, such as death within 30 days, how long patients stay in the hospital or in the ICU, whether they need ICU care, and how often doctors change antibiotics after lab results are available and why.

Who might be eligible? The study focuses on adults (18 and older) who have had a solid organ transplant and a single-type bloodstream infection caused by certain bacteria, treated at Fondazione IRCCS Ca’ Granda Policlinico in Milan between 2015 and 2023. People with infections caused by more than one organism or who received antibiotics more than 48 hours before or after the blood culture were not included. This is a retrospective, single-center cohort study (looking back at past records) and plans to include about 150 patients. There is no new treatment involved; the study simply analyzes past care to see if using the hospital’s antibiogram to guide initial antibiotic choices is associated with better outcomes. The study is currently enrolling by invitation, with results expected in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age ≥ 18 years
  • Being SOT
  • Monomicrobial bloodstream infection due to Acinetobacter baumannii, Enterobacter spp., Enterococcus faecalis, Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Klebsiella other-than pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Staphylococcus lugdunensis, and Streptococcus spp.
  • Hospitalization in Fondazione IRCCS Cà Granda Policlinico of Milano from 2015 to 2023.
  • Exclusion Criteria:
  • Antibiotic therapy administration outside 48h before-after blood culture collection.
  • Polymicrobial bloodstream infections.

About Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is a prestigious research and clinical care institution based in Milan, Italy. Renowned for its commitment to advancing medical knowledge and improving patient outcomes, the foundation integrates cutting-edge research with high-quality healthcare services. It serves as a hub for innovative clinical trials, fostering collaborations among healthcare professionals, researchers, and academic institutions. With a focus on various therapeutic areas, the foundation aims to translate scientific discoveries into effective treatments, ultimately enhancing the quality of life for patients.

Locations

Milano, Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported