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

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What is this study about?

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.

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 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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
Hippokration Hospital	Athens	Greece
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Umbal – Prof. D-R Stoyan Kirkovich AD	Stara Zagora	Bulgaria
Fiyxzbmsq Pssa Lk Isofhsetllczu Bebeixsvx Dje Hfhutxaw Upoyvoiymngvr Lo Phv	Madrid	Spain
Mfdthcp Cxgkna Acitm Izh Psoafdj Eixz	Sofia	Bulgaria
Utaocaokqf Gjizjos Huiiorox Airocjo	Athens	Greece

Trial status

Country	Status	Recruitment Start
Bulgaria	Not yet recruiting	01.11.2023
Greece	Not yet recruiting	01.11.2023
Spain	Not yet recruiting	01.11.2023

Trial locations

Investigated drugs:

Cefiderocol

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.

Investigated diseases:

Bacterial infection

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 ID:

2023-503757-35-00

Protocol code:

1904R2136

Trial Phase:

Therapeutic exploratory (Phase II)

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

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