Targeted peri‑operative prophylaxis using eravacycline (drug combination) versus standard prophylaxis in liver transplant patients colonized with CPE

Enrollment and consent

After being identified as eligible, you sign a consent form that explains the purpose of the study and what will be required of you.

Baseline assessments

Before any study medication is given, you undergo a series of assessments that include a test for carbapenemase‑producing enterobacterales (cpe) colonization, collection of medical history, physical examination, and routine laboratory tests.

Randomization to prophylaxis strategy

Based on a computer‑generated schedule, you are assigned to either targeted peri‑operative prophylaxis (t‑pap) or standard peri‑operative prophylaxis (s‑pap). the assignment is not influenced by you or the care team.

Administration of study medication before surgery

Shortly before the liver transplantation, you receive an intravenous infusion of the medication assigned to your group. the medication is given through a vein over a short period of time.

The possible study medications and their doses are:

• xerava: eravacycline 2 mg/kg body weight
• recarbrio: combination of cilastatin sodium, imipenem and relebactam 4000 mg total
• fetcroja: cefiderocol 6000 mg
• zavicefta: ceftazidime 7500 mg combined with avibactam
• vaborem: meropenem 6600 mg combined with vaborbactam
• emblaveo: aztreonam 10.67 g combined with avibactam
• azactam: aztreonam 6000 mg
• tygacil: tigecycline 150 mg
• amoxicillina e acido clavulánico sandoz: amoxicillin 6600 mg combined with clavulanic acid
• tazocin®: piperacillin 18000 mg combined with tazobactam

Each medication is prepared as a solution for infusion and given by intravenous infusion according to the study protocol.

Liver transplantation surgery

The transplant operation is performed as scheduled. the study medication is intended to protect you from infection during the peri‑operative period.

Post‑operative prophylaxis period

After the surgery, the assigned antibiotic may be continued for a period that can extend up to 14 days, depending on the protocol for your group. the exact frequency (for example, once daily) and total duration are defined by the study schedule.

Monitoring for adverse events

During the prophylaxis period and for 7 days after the first dose, you are monitored for possible side effects such as neurotoxicity, kidney toxicity, or allergic reactions. any such events are recorded as adverse events.

Follow‑up assessments

You return for follow‑up visits at 14, 30, 60, and 90 days after the transplant. at each visit, clinical examinations, laboratory tests, and samples for gut microbiome analysis are performed to evaluate infection status and overall health.

Final study evaluations

At the 30‑, 60‑, and 90‑day time points, the study records whether you have any cpe or non‑cpe infections, your colonization status, and whether you are alive. these outcomes are used to compare the effectiveness of the targeted and standard prophylaxis strategies.