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Study of antibiotic treatment effectiveness in critically ill patients receiving drug combination therapy

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

This clinical trial aims to study antibiotic levels in critically ill patients receiving intravenous antibiotic treatment for serious infections. The study will measure how well different antibiotics like vancomycin, meropenem, piperacillin, ceftazidime, and other commonly used antibiotics reach effective concentrations in the blood of patients in intensive care units.

The research will analyze blood samples from patients who are receiving antibiotics as part of their normal treatment in the intensive care unit. The main goal is to determine if current antibiotic dosing practices achieve the right levels of medication in the blood to effectively treat infections in critically ill patients.

The study will track antibiotic concentrations in the blood and monitor treatment outcomes, including how well the infection responds to treatment and any side effects that may occur. This information will help improve understanding of how antibiotics work in critically ill patients and may lead to better dosing recommendations for future treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial qualification

    You must be admitted to an Intensive Care Unit (ICU) to participate in the study

    You need to be receiving one of the specified intravenous antibiotics for treating an infection

    You must have been taking the study antibiotic for at least 24 hours

    Your age must be at least 1 month (corrected gestational age)

  2. Step 2

    Medical requirements

    You must have suitable intravenous or intra-arterial access for blood sample collection

    The medical team will monitor your antibiotic levels in blood samples

    The study will track how the antibiotics work in your body through blood measurements

  3. Step 3

    Monitoring period

    Your antibiotic levels will be measured throughout the treatment

    The medical team will monitor your condition for up to 30 days after starting the antibiotic

    They will check if the treatment is successful and record any side effects

    Additional monitoring will continue for 14 days to check for resistant organisms

  4. Step 4

    Study completion

    The medical team will record how many days you spent outside the ICU within the 30-day period

    They will document your health status at day 14 and day 30 after starting the antibiotic

    The study will track any adverse events related to the antibiotic treatment

Who can join the trial?

8 criteria

  • You must be a patient in the Intensive Care Unit (ICU)
  • You must be currently receiving intravenous antibiotics (medicine given through a vein) to treat an infection
  • You must have a suitable intravenous or intra-arterial line (a tube inserted into your vein or artery) that allows for blood sample collection
  • You must be at least 1 month old (adjusted for premature birth if applicable)
  • You must have been receiving the study antibiotic for at least 24 hours
  • You must be able to provide informed consent (written permission to participate in the study) or have someone legally authorized to provide consent on your behalf
  • Both male and female patients can participate
  • Adults and children can participate in the study

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Pregnant or breastfeeding women
  • Known allergic reactions to any of the study antibiotics
  • Severe kidney disease requiring dialysis (a treatment that filters waste from blood when kidneys don't work properly)
  • Severe liver disease (where the liver is not functioning properly)
  • Patients receiving palliative care (care focused on comfort rather than cure)
  • Inability to provide informed consent
  • Participation in another clinical trial within the past 30 days
  • Patients with compromised immune system (weakened ability to fight infections)
  • History of severe adverse reactions to antibiotics
  • Patients with conditions that might interfere with antibiotic absorption
  • Terminal illness with life expectancy less than 3 months
  • Active cancer treatment that might affect antibiotic effectiveness
  • Severe burns affecting more than 20% of body surface
  • Patients requiring specialized medication that could interact with study antibiotics
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Investigated drugs

Antibiotics are medications used to treat bacterial infections. In this study, researchers are examining how these medications work in critically ill patients who are in intensive care units. The study aims to measure the levels of antibiotics in patients' bodies to ensure they are receiving the right amount of medication to effectively treat their infections. This is important because critically ill patients may process medications differently than other patients, which could affect how well the antibiotics work. The study appears to be focused on measuring antibiotic concentrations in general, rather than testing specific antibiotic products.

What is already known about the treatment

  • BENZYLPENICILLIN

    This drug is given by intravenous injection and contains three forms of penicillin (procaine, benzathine, and potassium). It is an approved antibiotic that has been used for many years to treat serious bacterial infections. It works by stopping bacteria from building their cell walls, which kills them. It belongs to the penicillin class of beta‑lactam antibiotics.

  • LINEZOLID

    Administered as an IV infusion, linezolid is a fully approved oral and injectable antibiotic for serious infections. It is widely studied and used in hospitals worldwide. It blocks the ability of bacteria to make proteins, stopping them from growing. It is classified as an oxazolidinone antibiotic.

  • MEROPENEM

    Given by IV infusion, meropenem is an approved broad‑spectrum carbapenem antibiotic for severe infections. It is commonly used in intensive‑care units and has extensive clinical data. It destroys bacterial cell walls by binding to penicillin‑binding proteins. It belongs to the carbapenem subclass of beta‑lactam antibiotics.

  • CEFIDEROCOL

    This medication is administered intravenously as a single infusion and is approved for treating complicated urinary‑tract infections. It is a newer cephalosporin with growing clinical evidence. It works by inhibiting bacterial cell‑wall synthesis, leading to cell death. It is classified as a siderophore‑conjugated cephalosporin antibiotic.

  • IMIPENEM AND CILASTATIN

    The combination is given by IV infusion; imipenem is the active antibiotic and cilastatin protects it from kidney breakdown. It is an approved treatment for a wide range of serious infections. Imipenem stops bacteria from forming cell walls, while cilastatin does not have antibiotic activity itself. The pair is classified as a carbapenem antibiotic with a renal‑protective agent.

  • LEVOFLOXACIN

    Delivered by IV infusion, levofloxacin is an approved fluoroquinolone used for many serious bacterial infections. It has a long history of use and extensive research. It works by interfering with bacterial DNA replication, preventing the bacteria from multiplying. It belongs to the fluoroquinolone class of antibiotics.

Investigated diseases

  • Serious Bacterial Infection in Critical Care

    A condition where harmful bacteria invade the body of critically ill patients, causing severe infection that affects vital organs and body systems. The infection develops rapidly and can occur in various parts of the body, including the bloodstream, lungs, or other organs. These infections often emerge when patients are already weakened by other medical conditions or procedures. The body's immune response to the infection can lead to widespread inflammation. Patients typically experience symptoms such as fever, altered vital signs, and organ dysfunction.

  • Methicillin-Resistant Staphylococcus Aureus (MRSA)

    A type of bacteria that has developed resistance to many common antibiotics. MRSA can cause infections in different parts of the body, from skin infections to more serious internal infections. The bacteria can spread through direct contact with an infected wound or by sharing personal items that have touched infected skin. MRSA infections often begin as swollen, painful red bumps that may resemble pimples or spider bites. The affected area might be warm to touch and full of pus or other drainage.

Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516232-10-00Protocol codeLOCAL/2024/CR-03Estimated enrolment1 250 patientsSponsorCentre Hospitalier Universitaire De Nimes

sourced from the EU Clinical Trials Register and site verification

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