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

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What is this study about?

Patients who carry carbapenemase-producing Enterobacterales and are scheduled for liver transplantation are at risk of developing serious infections after the operation. The study compares a targeted antibiotic plan that uses drugs such as eravacycline, imipenem, cefiderocol, tigecycline and amoxicillin with the standard prophylactic regimen normally given around the time of surgery.

The purpose of the trial is to see whether the targeted plan reduces early infections caused by these resistant bacteria. Participants will be assigned to receive either the targeted or the standard regimen during the peri‑operative period, and they will be monitored through a series of visits up to 90 days after transplantation to record any infections, side effects, and overall health outcomes.

1 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.

2 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.

3 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.

4 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.

5 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.

6 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.

7 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.

8 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.

9 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.

Who Can Join the Study?

  • Adult (age 18 or older) patients who have a type of bacteria called CPE living on their body and are scheduled for a liver transplantation (surgery to replace a diseased liver with a donor liver).
  • Patient must sign an informed consent form, which means they understand the study and agree to take part.

Who Cannot Join the Study?

  • You cannot join if you have an active infection caused by any Gram‑negative bacteria at the time of your liver transplant. (Gram‑negative bacteria are a large group of germs that can cause serious infections.)
  • You cannot join if you are at high risk of getting a donor‑derived CPE infection. This includes situations where the organ donor was known to carry or be infected with CPE (a type of germ that resists many antibiotics) or when CPE was found in the donor’s blood or organ preservation fluid.
  • You cannot join if you are allergic (have hypersensitivity) to the study drug itself or to any of its inactive ingredients (excipients). (Hypersensitivity means a strong allergic reaction.)
  • You cannot join if you are currently pregnant or breastfeeding.
  • You cannot join if you have taken part in another clinical study where an investigational drug was given within the last 30 days, or within five times the drug’s half‑life (the time it takes for half of the drug to leave your body), whichever period is longer.
  • You cannot join if you have a history of severe immediate allergic reactions (anaphylaxis) to any beta‑lactam agents such as cephalosporins, carbapenems, or monobactams. (Beta‑lactam agents are a common class of antibiotics.)
  • You cannot join if you are already carrying (colonized by) germs that are resistant to all of the study’s Investigational Medicinal Products (IMPs). (Colonization means the germs are present on or in your body without causing an infection, and resistant means the germs are not killed by those medicines.)

Where you can join this trial?

Verified and Recommended Sites

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Other Sites

Site Name City Country Status
Ajjhorb Uewjk Sxvidzdpd Lmeuyn Dm Bsvtgfc Bologna Italy
Ayfjsjh Oycevwuyppz Uinnskglfabqw Cxqfvmwvvzai Doene Swszof E Dljtk Sjpalgm Di Teafjc Turin Italy
Aqtcstd Oqquzddnlxr Uspovghkihwql Ptmart Pisa Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not yet recruiting
01.09.2026

Trial locations

Investigated Drugs:

Xerava is an intravenous antibiotic that belongs to a class called tetracyclines. In this study it is used as a targeted preventive treatment given during liver transplantation to try to stop infections caused by bacteria that are resistant to many other drugs.

Recarbrio is a combination IV drug that includes three ingredients: imipenem, cilastatin, and relebactam. Together they work to kill a broad range of bacteria, including those that produce enzymes making them resistant to carbapenem antibiotics. It is tested as a targeted prophylaxis to protect transplant patients from hard‑to‑treat infections.

Fetcroja is an IV antibiotic called cefiderocol. It is designed to enter bacteria through iron‑transport channels and kill many Gram‑negative organisms, even those that are resistant to most other medicines. In the trial it is given as a targeted preventive therapy during the operation.

Zavicefta combines the antibiotic ceftazidime with a substance called avibactam that blocks bacterial enzymes that destroy antibiotics. This IV medicine helps treat infections caused by resistant Gram‑negative bacteria and is being evaluated as a targeted prophylactic option for liver transplant patients.

Vaborem is an IV combination of meropenem and vaborbactam. Meropenem is a powerful antibiotic, and vaborbactam protects it by stopping bacterial enzymes that would otherwise make it ineffective. The drug is tested as a targeted preventive treatment to reduce post‑surgery infections.

Emblaveo contains aztreonam together with avibactam. Aztreonam attacks certain Gram‑negative bacteria, and avibactam helps it work against bacteria that produce enzyme resistance. This IV medicine is used as another targeted prophylaxis option in the study.

Azactam is an IV form of aztreonam, an antibiotic that fights Gram‑negative bacteria. In the trial it serves as a simpler version of the aztreonam‑based therapy, helping to prevent infections after liver transplantation.

Tygacil is the brand name for tigecycline, an IV antibiotic that works against a wide range of bacteria, including some that are resistant to other drugs. It is used as a standard (comparator) prophylactic treatment to see how it compares with the targeted options.

Amoxicillin and clavulanic acid (Sandoz) is an IV combination where amoxicillin kills bacteria and clavulanic acid blocks enzymes that some bacteria use to resist amoxicillin. This familiar antibiotic pair is used as a standard prophylaxis comparator in the study.

Tazocin (piperacillin/tazobactam) is an IV antibiotic combination. Piperacillin attacks many types of bacteria, and tazobactam protects it from bacterial enzymes that would inactivate it. It is another standard prophylactic therapy used for comparison with the targeted regimens.

Carbapenemase‑producing Enterobacteriaceae colonization – Colonization means the bacteria are present in the gut but are not causing symptoms. In patients who receive a liver transplant, the immune system is suppressed, which can allow the bacteria to multiply. Over time the bacteria may spread from the intestine to other body sites, leading to infection. The condition can persist for weeks after transplantation if the bacteria are not cleared. Monitoring the amount and types of bacteria helps understand how the colonization changes after surgery.

Trial ID:
2025-523453-34-00
Protocol code:
TAILOR
Trial Phase:
Therapeutic confirmatory (Phase III)

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