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Study of Subcutaneous Ceftazidime and Avibactam in Adults with Complicated Intra‑Abdominal, Urinary Tract, or Hospital‑Acquired Pneumonia Infections

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on serious bacterial infection types, including complicated intra-abdominal infection, complicated urinary tract infection, hospital-acquired pneumonia, ventilator-associated pneumonia, and bacteraemia caused by aerobic Gram-negative organisms. The treatment being tested is a combination of two antibiotics, ceftazidime and avibactam, which are given by a subcutaneous injection (a shot placed under the skin).

The purpose of the study is to evaluate how much of the medication remains freely available in the blood over time while also checking kidney function. Participants will receive the medication on a regular schedule and will have small blood samples taken on days 3, 5, 7, and 10, with a kidney test performed at the same time. This process uses therapeutic drug monitoring, which simply means measuring drug levels to make sure they are in a safe and effective range.

During the study, patients will be observed for any side effects, and routine health checks will be performed. The overall period of participation lasts a few weeks, and the study team will closely watch each participant’s wellbeing throughout.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial Visit and Consent

    You will meet the study staff on the day you join the trial. During this visit you will sign the informed consent form, confirming that you understand the purpose of the study and agree to take part.

    The staff will review your medical history and confirm that you have a bacterial infection that meets the study criteria.

  2. Step 2

    Baseline Assessments

    Before any medication is given, a series of baseline tests will be performed. These include blood tests to measure kidney function (creatinine) and other routine laboratory values.

    The results will be used as a reference point for later comparisons during the trial.

  3. Step 3

    Start of Medication

    You will receive a subcutaneous infusion of ceftazidime/avibactam powder reconstituted to a solution for infusion.

    The prescribed dose is 7.5 g of the combined medication, administered according to the study schedule.

    The infusion is given under the supervision of study personnel to ensure correct delivery.

  4. Step 4

    Ongoing Treatment and Monitoring

    After the first dose, you will continue to receive the medication as directed by the study protocol. The exact frequency and total duration are defined by the trial schedule.

    Study staff will observe you for any adverse reactions and will perform routine checks of vital signs.

  5. Step 5

    Therapeutic Drug Monitoring (TDM) and Creatinine Measurements

    Blood samples will be taken on Day 3, Day 5, Day 7, and Day 10 to measure the free concentration of ceftazidime in your bloodstream.

    At the same time, a creatinine test will be performed to assess kidney function.

    These measurements help determine how the drug is processed in your body and ensure safe dosing.

  6. Step 6

    Final Assessment and End of Study

    When the medication course is completed, a final set of assessments will be performed, including a repeat of the laboratory tests.

    The study staff will review all collected data and discuss any final observations with you.

Who can join the trial?

8 criteria

  • Give a signed, free written informed consent (a paper that shows you understand the study and agree to take part) before any study procedures begin.
  • Be at least 18 years old on the day you join the study.
  • Be a male or female patient.
  • Be staying in a regular medical ward (not the intensive care unit) that is allowed to enroll patients in this study.
  • Have a medical reason for your doctor to prescribe the antibiotic combination ceftazidime/avibactam according to normal hospital practice.
  • Have already started receiving the medicine through an intravenous (IV) line (a tube placed into a vein) before you are enrolled, or during the first 1‑3 days of the study, and be eligible to later switch to a subcutaneous injection (a shot given under the skin) as planned by the study.
  • Have a creatinine clearance greater than 50 mL/min, which is a lab test that shows your kidneys are working well enough.
  • If you are a woman who could become pregnant, you must have a negative pregnancy test before joining the study, following hospital rules.

Who cannot join the trial?

11 criteria

  • Known hypersensitivity (allergy) to ceftazidime, avibactam, cephalosporins, other beta‑lactam antibiotics, beta‑lactamase inhibitors, or any ingredient in the medication.
  • Pregnant or breastfeeding women, or women who plan to become pregnant during the study period.
  • No current medical need for ceftazidime/avibactam treatment at the time of screening.
  • If laboratory results already show that the infection is resistant to ceftazidime/avibactam and the doctor decides the drug is not appropriate.
  • Creatinine clearance of 50 mL/min or less at screening (a test that measures how well the kidneys are working).
  • Admission to an intensive care unit (ICU), a special hospital area for very sick patients.
  • Starting invasive or non‑invasive mechanical ventilation (a machine that helps you breathe).
  • Starting renal replacement therapy or dialysis (machines that clean the blood when kidneys are not working well).
  • Starting vasopressor support with norepinephrine (or a similar drug that raises blood pressure in critically ill patients).
  • Any medical condition, physical exam finding, metabolic problem, or lab abnormality that makes using ceftazidime/avibactam unsafe, could affect study results, or puts the participant at unacceptable risk, according to the doctor.
  • Inability to follow study procedures or attend required follow‑up visits.
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Investigated drugs

Ceftazidime/Avibactam is an antibiotic combination that includes ceftazidime, which kills many types of bacteria, and avibactam, which helps protect ceftazidime from being broken down by bacterial enzymes. In this study the drug is given by a subcutaneous injection (under the skin) as a solution for infusion. The trial is testing how the drug behaves in the body when given this way, by measuring the amount of free ceftazidime in the blood on several days and checking kidney function at the same time.

What is already known about the treatment

Zavicefta 2 g/0.5 g powder for concentrate for solution for infusion - It is supplied as a powder that is mixed with liquid and given under the skin as an infusion; it is an approved antibiotic that combines ceftazidime and avibactam and is listed in current medical references. It is used to treat serious bacterial infections such as complicated abdominal infections, urinary tract infections, and hospital‑acquired pneumonia when other treatments are limited. The drug works by stopping bacteria from building their protective cell walls and by adding a substance that blocks an enzyme that would otherwise destroy the antibiotic. It belongs to the class of cephalosporin antibiotics combined with a beta‑lactamase inhibitor.

Investigated diseases

  • Bacterial infection

    A condition caused by bacteria that invade the body, leading to symptoms such as fever, pain, or swelling. The infection can spread from the entry site to other tissues, progressing from localized to systemic involvement.

  • Complicated intra-abdominal infection

    An infection that occurs within the abdominal cavity and involves organs or spaces beyond a simple appendicitis. It often arises after surgery, perforation, or trauma and can spread to surrounding tissues, leading to abscess formation and sepsis if untreated.

  • Complicated urinary tract infection, including pyelonephritis

    A urinary infection that extends to the kidney or involves structural abnormalities, stones, or obstruction. The infection may begin in the bladder and ascend to the kidneys, causing inflammation, pain, and possible spread to the bloodstream.

  • Hospital-acquired pneumonia, including ventilator-associated pneumonia

    A lung infection that develops at least 48 hours after admission to a hospital or after mechanical ventilation. The infection starts in the airways and can progress to involve the lung tissue, causing worsening breathing difficulty and possible spread to other organs.

  • Bacteraemia associated with intra-abdominal, urinary or respiratory infections

    The presence of bacteria in the bloodstream that originates from an infection in the abdomen, urinary tract, or lungs. The bacteria can travel through the blood, leading to systemic inflammation and organ dysfunction if not cleared.

  • Aerobic Gram-negative bacterial infection in patients with limited treatment options

    An infection caused by oxygen‑using Gram-negative bacteria such as Pseudomonas or Enterobacter that are resistant to many antibiotics. The infection can spread rapidly and may become difficult to control, leading to worsening symptoms and possible spread to multiple sites.

Trial detailsLast updated 11 Nov 2026
Age18+ yearsPhasePhase IITrial ID2026-527599-10-00Estimated enrolment45 patientsSponsorAzienda Sanitaria Universitaria Friuli Centrale

sourced from the EU Clinical Trials Register and site verification

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