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Study on Cefiderocol for Treating Gram-negative Bacterial Infections in Hospitalized Infants Under 3 Months

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 is focused on studying aerobic Gram-negative bacterial infections in young children. These infections are caused by a type of bacteria that need oxygen to grow and can lead to serious health issues. The study will use a medication called cefiderocol, also known by its code name S-649266. Cefiderocol is a type of antibiotic that is given through an infusion, which means it is delivered directly into the bloodstream through a vein. The purpose of the study is to understand how cefiderocol behaves in the body and to check its safety and how well it is tolerated by the patients.

The study will involve children from birth to less than three months old who are hospitalized with suspected or confirmed Gram-negative bacterial infections. These infections can include conditions like complicated urinary tract infections, complicated intra-abdominal infections, hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, and bloodstream infections or sepsis. The study will observe how the medication is processed in the body after both a single dose and multiple doses.

Throughout the study, researchers will monitor the children for any side effects and changes in vital signs, which are basic measures of health like heart rate and temperature. They will also conduct physical examinations and laboratory tests to ensure the safety of the participants. The study aims to provide valuable information on the use of cefiderocol in treating these serious infections in very young children.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    The study involves infants from birth to less than 3 months of age who are hospitalized with suspected or confirmed aerobic Gram-negative bacterial infections.

    Participation requires written informed consent from a parent or legally authorized representative.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility, including a review of the infant's medical history and current health status.

  3. Step 3

    Single-dose administration

    The infant will receive a single dose of cefiderocol, administered as a solution for infusion. This is a type of antibiotic treatment given through an IV (intravenous) line.

  4. Step 4

    Monitoring after single dose

    After the single dose, the infant will be monitored for specific parameters such as the maximum concentration of the drug in the blood (Cmax), the area under the concentration-time curve (AUC0-inf), and the half-life of the drug (t1/2).

  5. Step 5

    Multiple-dose administration

    If the infant requires further treatment, multiple doses of cefiderocol may be administered. This phase should begin within 72 hours of starting other standard antibiotic treatments.

    The minimum number of doses given will be four.

  6. Step 6

    Monitoring after multiple doses

    Monitoring will continue to assess the drug's maximum concentration (Cmax), the area under the concentration-time curve over a dosing interval (AUC0-τ), and the half-life (t1/2) after multiple doses.

  7. Step 7

    Safety and health assessments

    Throughout the study, the infant's health will be closely monitored for any adverse events, changes in vital signs, and results from physical examinations and laboratory tests.

  8. Step 8

    Completion of the study

    The study is expected to conclude by August 30, 2024. At the end of the study, a final assessment will be conducted to evaluate the overall health and response to the treatment.

Who can join the trial?

4 criteria

  • Parents or legally authorized representatives must provide written permission for the infant to join the study.
  • The infant must be in the hospital and be from birth to less than 3 months old (less than 90 days) when the permission is given. Premature infants can join if they were born at least 26 weeks into the pregnancy, are 0 to 3 months old, and weigh at least 1 kilogram.
  • The infant needs treatment with antibiotics given through a vein (IV) for infections caused by certain bacteria called **aerobic Gram-negative bacteria**. These infections can include complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI), hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP), and bloodstream infections or sepsis (BSI/sepsis).
  • For the part of the study with multiple doses, the infant must start the study within 72 hours of beginning treatment with standard antibiotics for the main infection.

Who cannot join the trial?

4 criteria

  • Patients who are not hospitalized cannot participate.
  • Patients who are not from birth to less than 3 months of age cannot participate.
  • Patients without suspected or confirmed **aerobic Gram-negative bacterial infections** cannot participate. These are infections caused by certain types of bacteria that need oxygen to grow.
  • Patients who have conditions other than those specified, such as **cUTI** (complicated urinary tract infection), **cIAI** (complicated intra-abdominal infection), **HABP/VABP** (hospital-acquired or ventilator-associated bacterial pneumonia), or **BSI/sepsis** (bloodstream infection or a severe response to infection), cannot participate.
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Investigated drugs

Cefiderocol is an antibiotic used in this clinical trial to treat young children who are hospitalized with suspected or confirmed infections caused by aerobic Gram-negative bacteria. The study aims to understand how the body processes this medication and to evaluate its safety and tolerability in infants from birth to less than 3 months old. Cefiderocol is administered to help fight serious infections, including complicated urinary tract infections, complicated intra-abdominal infections, hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, and bloodstream infections or sepsis.

What is already known about the treatment

Cefiderocol – Cefiderocol is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating aerobic Gram-negative bacterial infections in hospitalized pediatric patients from birth to less than 3 months of age. It is a relatively new antibiotic in medical literature, primarily used for complicated urinary tract infections, intra-abdominal infections, hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, and bloodstream infections or sepsis. The drug works by inhibiting bacterial cell wall synthesis, specifically targeting Gram-negative bacteria by utilizing a unique mechanism that involves binding to iron, which bacteria need to survive. Cefiderocol is classified as a cephalosporin antibiotic, known for its broad-spectrum antibacterial activity.

Investigated diseases

Aerobic Gram-negative bacterial infections – These infections are caused by a group of bacteria that do not require oxygen for growth and are characterized by their resistance to many antibiotics. They can lead to various conditions, including complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI), hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), and bloodstream infections (BSI) or sepsis. The bacteria invade the body, often through wounds or medical devices, and can spread rapidly, causing inflammation and damage to tissues. Symptoms vary depending on the site of infection but often include fever, chills, and localized pain or discomfort. These infections are particularly concerning in healthcare settings due to their potential for rapid spread and resistance to treatment.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IITrial ID2023-503757-35-00Protocol code1904R2136Estimated enrolment40 patientsSponsorShionogi B.V.

sourced from the EU Clinical Trials Register and site verification

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