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Clinical Trials in Italy / NCT06718517
Recruiting Observational

Impact of a TDM-guided ECPA Program for Optimizing Pharmacodynamic Target Attainment of Continuous Infusion Beta-lactam-based Regimen

NCT06718517 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2024-08-28
Last updated
2024-12-05

Condition(s) studied

Liver Transplant Infection

Study summary

Previous studies have clearly demonstrated a significant impact of optimised antibiotic therapy based on a TDM-guided approach in reducing the clinical and microbiological failure rate and in improving the achievement of an optimal pharmacokinetic/pharmacodynamic target. However, no study has yet evaluated this aspect in the specific scenario of liver transplant patients with documented infections with Gram-negative pathogens.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. adult OLT recipients (age ≥ 18 years); 2. documented Gram-negative infections occurring in the first 90 days after transplantation; 3. treatment with beta-lactam based-regimens; 4. signed informed consent. Exclusion Criteria: 1. patients receiving beta-lactam-based regimens for less than 48 hours; 2. patients with isolation of a Gram-negative resistant to all available beta-lactam classes; 3. patients on palliative care and/or not resuscitation order.

Primary outcome measure(s)

  • Verify if the attainment of optimal beta-lactam PK/PD targets improves the rate of microbiological eradication in OLT recipients with documented Gram-negative infections — At 30-days from starting antibiotic therapy
    Microbiological eradication, defined as the absence of the index pathogen from the primary site of infection in at least two subsequent assessments Dichotomous variable (yes/no)
  • Verify if the attainment of optimal beta-lactam PK/PD targets improves the rate of clinical cure in OLT recipients with documented Gram-negative infections — At 30-days from starting antibiotic therapy
    Clinical cure, defined as complete resolution of signs and symptoms of the infection coupled with documented microbiological eradication at the end of treatment and the absence of recurrence or relapse at 30-day Dichotomous variable (yes/no)

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Italy Recruiting

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Other trials for the same condition

Impact of Culture of Perfusion Fluid on Donor-derived Infection Management and Outcome in Liver and Kidney Transplant Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06718517 on ClinicalTrials.gov ↗ ← All trials in Italy