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Evaluation of Optimized Ceftazidime Dosing Regimen Versus Standard Treatment for Critical Care Patients with Sepsis

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 evaluates a new dosing approach for ceftazidime, an antibiotic medication used to treat sepsis. Sepsis is a serious condition that occurs when the body's response to an infection damages its own tissues and organs, potentially leading to organ failure and death if not treated promptly. The study aims to compare an optimized ceftazidime dosing regimen with the standard regimen in patients receiving critical care.

The trial focuses on finding the best way to administer ceftazidime to quickly reach and maintain effective medication levels in the bloodstream of critically ill patients. Participants will be adults in critical care units who have infections requiring ceftazidime treatment. During the study, researchers will monitor medication levels in the blood at specific time points after administration to determine if the optimized regimen achieves target concentrations more effectively than standard dosing.

The study will also track patients' organ function using a special assessment tool, monitor for potential side effects such as seizures or altered consciousness, and evaluate kidney function throughout the treatment period. This research could lead to improved antibiotic dosing strategies for critically ill patients with sepsis.

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

    Enrollment and Initial Assessment

    After joining the study, your overall health condition will be assessed using the SOFA score (Sepsis-related Organ Failure Assessment). This score evaluates six body systems: respiratory, cardiovascular, liver, blood clotting, kidney, and neurological function. Each system receives a score from 0-4, with a total possible score of 0-24.

    You will be hospitalized in critical care for at least 72 hours for treatment of an infection requiring ceftazidime (an antibiotic medication).

    An arterial catheter will be used for blood sampling throughout the study.

  2. Step 2

    Treatment Assignment

    You will be assigned to receive either the standard ceftazidime regimen or an optimized ceftazidime regimen designed to reach and maintain target concentrations more efficiently.

    The goal of the optimized regimen is to achieve a blood concentration of at least 35 mg/L at both 3 hours and 24 hours after the first dose, while staying below the toxicity threshold of 100 mg/L.

  3. Step 3

    Monitoring and Testing

    Blood samples will be collected through your arterial catheter at specific timepoints, including at 3 hours and 24 hours after the first dose of ceftazidime, to measure the concentration of the antibiotic in your bloodstream.

    Your kidney function will be regularly assessed using several measurements including: creatinemia (creatinine levels in blood), cystatin, CKD-EPI (a calculation method), creatinuria/creatininemia ratio, and eGFR (estimated glomerular filtration rate).

    Your neurological status will be monitored for any signs of adverse events, including seizures, myoclonus (muscle jerking), encephalopathy (brain dysfunction), delirium, or altered consciousness (measured by Glasgow score).

  4. Step 4

    Ongoing Treatment and Assessment

    You will continue to receive ceftazidime treatment according to your assigned regimen throughout your stay in critical care.

    Your health status will be continuously monitored for any signs of overdose (defined as a concentration greater than 100 mg/L in your bloodstream).

    Your SOFA score will be reassessed on Day 7 to track changes in your condition.

  5. Step 5

    Follow-up Period

    You will be monitored for up to 28 days after starting treatment to track outcomes.

    The researchers will record how quickly the antibiotic reached effective levels in your bloodstream (the PK/PD targets).

    Any adverse events related to the treatment will be documented throughout the follow-up period.

Who can join the trial?

5 criteria

  • You must be at least 18 years old.
  • You must be hospitalized in critical care (intensive care unit) and expected to stay for at least 72 hours.
  • You must have an infection that your doctor believes could be treated with ceftazidime (an antibiotic medication).
  • You must have an arterial catheter (a thin tube inserted into an artery) already in place for blood sampling.
  • You must be affiliated with or entitled to benefits under a social security scheme.

Who cannot join the trial?

7 criteria

  • You cannot participate if you are pregnant or breastfeeding.
  • You cannot participate if you have a known allergy to ceftazidime (the antibiotic used in the study) or other similar antibiotics.
  • You cannot participate if you have severe kidney failure requiring dialysis (a procedure to filter waste from blood when kidneys cannot).
  • You cannot participate if you have severe liver disease.
  • You cannot participate if you are already taking part in another clinical trial.
  • You cannot participate if you have a condition that would prevent you from safely participating in the study, as determined by the study doctor.
  • You cannot participate if you are unable to provide informed consent (understand and agree to the study) and have no legal representative who can provide consent for you.
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Investigated drugs

Ceftazidime is an antibiotic medication used to treat various bacterial infections. It belongs to a class of antibiotics called cephalosporins. In this study, researchers are trying to find the best way to give this medication to critically ill patients to ensure they receive the optimal amount of the drug in their bloodstream.

What is already known about the treatment

Ceftazidime – A broad-spectrum antibiotic administered intravenously or intramuscularly to treat various bacterial infections, particularly in critically ill patients with sepsis. Ceftazidime belongs to the cephalosporin class of antibiotics and works by interfering with bacterial cell wall synthesis, leading to cell death. It is widely used in critical care settings for treating serious infections caused by gram-negative bacteria, including Pseudomonas aeruginosa. The FORTOPTIM_1 trial aims to compare an optimized dosing regimen against the standard approach to achieve faster and more consistent therapeutic levels in critically ill patients, potentially improving outcomes in severe infections.

Investigated diseases

Sepsis – A serious condition that occurs when the body's response to infection causes a chain reaction throughout the body. Sepsis involves a systemic inflammatory response triggered by infection, which can lead to widespread inflammation, tissue damage, and potential organ dysfunction. As sepsis progresses, it can affect multiple body systems, including the respiratory, cardiovascular, hepatic, renal, and neurological systems. The severity of sepsis is often measured by the degree of organ dysfunction using scoring systems like SOFA (Sepsis-related Organ Failure Assessment). Patients with sepsis may experience symptoms such as fever, increased heart rate, rapid breathing, confusion, and decreased urine output. Without proper management, sepsis can progress to severe sepsis and septic shock, causing significant physiological changes.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519783-41-00Protocol code24PH176_1Estimated enrolment128 patientsSponsorCentre Hospitalier Universitaire De Saint Etienne

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