Optimizing antibiotic therapy for liver transplant patients with infections
Impact of a TDM-guided ECPA Program for Optimizing Pharmacodynamic Target Attainment of Continuous Infusion Beta-lactam-based Regimen on Clinical Outcome in Orthotopic Liver Transplant Recipients With Documented Gram-negative Infections
This study is testing if using a special method to guide antibiotic treatment can help liver transplant patients with infections get better faster and avoid complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 65 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06718517 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of a therapeutic drug monitoring (TDM)-guided approach to optimize beta-lactam antibiotic therapy in liver transplant recipients with documented Gram-negative infections. It aims to determine whether achieving optimal pharmacokinetic/pharmacodynamic (PK/PD) targets improves microbiological eradication and clinical cure rates. Additionally, the study will identify factors predicting treatment failure and assess the relationship between PK/PD target attainment and antibiotic resistance development. The study focuses on patients within the first 90 days post-transplantation who are treated with beta-lactam regimens.
Who should consider this trial
Good fit: Ideal candidates are adult liver transplant recipients aged 18 and older with documented Gram-negative infections within 90 days post-transplant.
Not a fit: Patients receiving beta-lactam therapy for less than 48 hours or those with resistant Gram-negative infections will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for liver transplant patients suffering from infections.
How similar studies have performed: Previous studies have shown success with TDM-guided antibiotic therapy in other patient populations, but this specific application in liver transplant patients is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Federico Pea, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Federico Pea, MD
- Email: federico.pea@unibo.it
- Phone: 0039 051 214 3627
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.