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

NCT06874920 | Enrolling By Invitation

• 1 other identifier: 5392_20.11.2024_P_bis
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this observational study is to examine how using the hospital cumulative antibiogram to guide empirical antibiotic therapy affects outcomes in patients with bloodstream infections who have undergone solid organ transplants. The key question is: does the use of a hospital cumulative antibiogram reduce mortality and improve outcomes in these patients?

Conditions

Bacteremia; Transplant Recipient

Keywords

Hospital cumulative antibiogram; Solid organ transplant; Bloodstream infections

Outcome Measures

Primary Outcomes (1)

• 15-days mortality

  15 days from bloodstream infection

Secondary Outcomes (7)

• 30-days mortality

  30 days from bloodstream infection

• In-hospital mortality

  Up to 24 weeks

• Lenght of hospital stay

  Up to 24 weeks

• ICU admission

  Up to 24 weeks

• Lenght of ICU stay

  Up to 24 weeks

Study Arms (2)

Patients who was prescribed an empiric antibiotic therapy with OAS < 90%

Other: No intervention (observational study)

Patients who was prescribed an empiric antibiotic therapy with OAS ≥ 90%

Other: No intervention (observational study)

Interventions

No intervention (observational study) OTHER

No intervention (observational study)

Patients who was prescribed an empiric antibiotic therapy with OAS < 90%; Patients who was prescribed an empiric antibiotic therapy with OAS ≥ 90%

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

Solid organ transplant recipients with bloodstream infections.

You may qualify if:

• 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.

You may not qualify if:

• Antibiotic therapy administration outside 48h before-after blood culture collection.
• Polymicrobial bloodstream infections.

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Location

MeSH Terms

Conditions

Bacteremia; Sepsis

Interventions

Observation

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: March 13, 2025
• Study Start: December 3, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

IT (1)