Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Subcutaneous Meropenem for Patients with Bacterial Infections: A Study of Cmax Differences on Day 5

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search on your own, or looking for clinical trials for a rare disease?

What is this trial about?

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

The trial focuses on bacterial infections that need treatment with meropenem, an antibiotic that kills the germs causing the illness. The medicine is supplied as a liquid that is injected just under the skin (subcutaneous injection).

The purpose of the study is to compare the amount of drug that appears in the bloodstream after five days, known as Cmax, between participants who receive the antibiotic and those who receive a placebo.

Participants will be randomly assigned to receive either the antibiotic or the placebo by subcutaneous injection once daily for several days. Blood samples will be taken at scheduled times to check drug levels, and participants will be observed for any side effects. The study concludes after the final sample is collected.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Assessment

    After joining the study, you will meet the study team for a baseline assessment. This includes confirming that you have a bacterial infection that requires treatment with meropenem, checking vital signs, and reviewing your medical history.

    You will also receive instructions on how the study medication will be given and what to expect during the trial.

  2. Step 2

    First Dose Administration

    On the first day, a healthcare professional will prepare a solution containing meropenem at a dose of 3 g (grams). The medication will be given as a subcutaneous injection, meaning it is injected just under the skin.

    The injection will be performed in a clinical setting using sterile technique.

  3. Step 3

    Daily Dosing (Days 2–5)

    You will receive the same 3 g dose of meropenem by subcutaneous injection each day for the next four days. The exact time of day will be scheduled by the study staff.

    Each injection will be administered by a trained professional, and you will be observed for any immediate reactions.

  4. Step 4

    Day‑5 Blood Sample for Cmax Measurement

    On the fifth day, after the final dose, a blood sample will be taken to measure the Cmax of meropenem. Cmax refers to the highest concentration of the drug that appears in the blood after it is given.

    The sample will be collected by a qualified staff member and sent to the laboratory for analysis.

  5. Step 5

    Final Study Visit

    After the Day‑5 blood draw, you will attend a final visit where the study team will review any remaining observations, discuss any side effects you experienced, and answer any questions you may have about the study.

    No further doses of meropenem will be given after this visit.

Who can join the trial?

8 criteria

  • Provide a free, written, and informed consent before any study procedures are done.
  • Be at least 18 years old on the day you join the study.
  • Be either male or female.
  • Stay in a regular medical hospital ward (not the intensive care unit) that is allowed to enroll participants.
  • Have a doctor’s decision to treat a bacterial infection with meropenem, following local treatment guidelines.
  • Have already started meropenem given intravenously (through a vein) before randomization, and be able to continue the IV form or switch to the subcutaneous form (injected under the skin) as the study requires.
  • Show a creatinine clearance greater than 50 mL/min, which means your kidneys are working well enough for the medication.
  • If you are a woman who could become pregnant, have a negative pregnancy test before randomization.

Who cannot join the trial?

11 criteria

  • Known hypersensitivity (allergy) to meropenem, carbapenems, other beta‑lactam antibiotics, or any ingredient in the medication.
  • Being pregnant, breastfeeding, or planning to become pregnant while the study is running.
  • Not having a current medical reason to need meropenem treatment at the time of screening.
  • Having bacteria that are already proven to be resistant to meropenem before the study starts, making the drug ineffective.
  • Creatinine clearance of 50 mL/min or less, which means the kidneys are not filtering well enough.
  • Being admitted to an intensive care unit (a special hospital area for very sick patients).
  • Starting invasive mechanical ventilation (a breathing machine inserted through a tube) or non‑invasive mechanical ventilation (breathing support using a mask).
  • Starting renal replacement therapy or dialysis, which are treatments that clean the blood when the kidneys are not working.
  • Starting vasopressor support with norepinephrine/noradrenaline or a similar medication that raises blood pressure.
  • Having any health condition, physical finding, metabolic dysfunction (problem with body chemistry), or lab result that makes using meropenem unsafe, could affect the study’s results, or puts the person at unacceptable risk.
  • Being unable to follow the study procedures or attend follow‑up visits as required.
Clinical Trials Concierge

Prefer not to search on your own, or looking for clinical trials for a rare disease?

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Meropenem is a strong antibiotic used to treat serious bacterial infections. In this study, the medicine is given under the skin (subcutaneously) so researchers can see how much of the drug reaches the bloodstream after five days. They are measuring the highest level of the drug in the blood (Cmax) to understand how well this method of giving the medicine works compared to other groups.

What is already known about the treatment

Meropenem - It is supplied as a sterile solution for injection and is applied by subcutaneous injection. Meropenem is an approved, widely studied carbapenem antibiotic that appears in many clinical guidelines and research papers. It is used to treat serious bacterial infections such as pneumonia, urinary‑tract infections, and intra‑abdominal infections. The drug works by binding to bacterial enzymes that build the cell wall, stopping wall formation and leading to bacterial death, and it is classified as a carbapenem beta‑lactam antibiotic.

Investigated diseases

Bacterial infection - A bacterial infection occurs when pathogenic bacteria invade body tissues and multiply, provoking an immune response. Initially the infection may be limited to a specific site, such as the skin, respiratory tract, or urinary system, causing localized signs like redness, swelling, or pain. If the bacteria spread or the immune response is insufficient, the infection can extend to surrounding tissues and enter the bloodstream. This progression can lead to more widespread inflammation and involvement of multiple organ systems. Over time, the bacterial load can increase, intensifying symptoms and potentially causing functional impairment of the affected areas.
Trial detailsLast updated 15 Nov 2026
Age18+ yearsPhasePhase IITrial ID2026-527598-12-01Protocol codeSC-ANTIBIOTICS 2Estimated enrolment60 patientsSponsorAzienda Sanitaria Universitaria Friuli Centrale

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search on your own, or looking for clinical trials for a rare disease?

Tell us about your condition – we search every trial in Europe and connect you with the right site.