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

NCT06718517 | Recruiting

• 2 other identifiers: PK-PD_OLTRC-2024-2790678
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Transplant Infection

Keywords

Liver transplant; Beta-lactams; Gram-negative infections; PK/PD target attainment; Clinical outcome; Inflammatory biomarkers

Outcome Measures

Primary Outcomes (2)

• 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

  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)

  At 30-days from starting antibiotic therapy

• 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

  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)

  At 30-days from starting antibiotic therapy

Secondary Outcomes (4)

• To identify factors independently predicting failure in attaining early optimal beta-lactam PK/PD targets

  At 24 hours after starting antibiotic treatment

• To identify the relationship between the attainment of optimal beta-lactam PK/PD targets and antibiotic resistance development and post-OLT MDR colonization occurrence at 90-days

  At 90-days after starting antibiotic treatment

• To identify the association between the attainment of optimal PK/PD targets for beta-lactams and variation of inflammatory biomarkers (C-reactive protein [CRP], procalcitonin [PCT], and pro-/anti-inflammatory cytokines

  At 7-days after starting antibiotic treatment

• To evaluate the attainment of optimal beta-lactams PK/PD targets at the site of infection in case of pneumonia, intrabdominal and/or biliary infections

  At 7-days after starting antibiotic treatment

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 consecutive adult OLT recipients admitted to the Internal Medicine ward of the IRCCS Azienda Ospedaliero-Universitaria di Bologna for the treatment of severe organ failure who will be scheduled for liver transplantation will be enrolled in the study at the time of liver transplant.

You may qualify if:

• adult OLT recipients (age ≥ 18 years);
• documented Gram-negative infections occurring in the first 90 days after transplantation;
• treatment with beta-lactam based-regimens;
• signed informed consent.

You may not qualify if:

• patients receiving beta-lactam-based regimens for less than 48 hours;
• patients with isolation of a Gram-negative resistant to all available beta-lactam classes;
• patients on palliative care and/or not resuscitation order.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

Study Officials

• Federico Pea, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico Pea, MD

CONTACT

0039 051 214 3627; federico.pea@unibo.it

Milo Gatti, MD

CONTACT

0039 051 214 3627; milo.gatti2@unibo.it

Study Design

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

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 5, 2024
• Study Start: August 28, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)