CompletedPhase 2

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants

United States, South Africa, Taiwan30 participantsStarted 2024-03-14

Plain-language summary

The primary purpose of this study is to understand the pharmacokinetics (PK) of single and multiple doses of cefiderocol in children from birth to less than 3 months of age with suspected or confirmed aerobic Gram-negative bacterial infections.

Who can participate

Age range

3 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Written informed consent has been provided by parent(s) or legally authorized representative(s) in accordance with local regulatory requirements
. Hospitalized infants from birth to \< 3 months (\< 90 days) of age at the time written informed consent is provided. Enrollment of premature infants will not be restricted, but they must have a GA ≥ 26 weeks, PNA of 0 to 3 months, and weight of at least 1 kilogram (kg)
. Require systemic IV antibiotic treatment for suspected or confirmed aerobic Gram-negative infections including, but not limited to, complicated urinary tract infection, complicated intra-abdominal infection, hospital-acquired/ ventilator-associated bacterial pneumonia, and BSI/sepsis
. For the multiple-dose phase, within 72 hours of the start of potentially effective treatment with SOC antibiotics for the suspected or confirmed primary aerobic Gram-negative infection

Exclusion criteria

. Documented history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic
. Life expectancy of \< 72 hours after enrollment
. Urine output \< 1.0 milliliter (mL)/kg/hour within the 24 hours prior to study drug administration on Day 1
. Serum creatinine value greater than the maximum for GA and PNA shown below within the 24 hours prior to study drug administration on Day 1

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum Observed Plasma Concentration (Cmax) After a Single Dose of Cefiderocol

Timeframe: Up to 8 hours postdose

Cmax After a Minimum of 4 Doses of Cefiderocol

Timeframe: Up to 8 hours postdose

Area Under the Concentration-Time Curve Extrapolated From Time 0 to Infinity (AUC0-inf) After Single Dose of Cefiderocol

Timeframe: Up to 8 hours postdose

Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-†) After a Minimum of 4 Doses of Cefiderocol

Timeframe: Up to 3 hours

Terminal Elimination Half-Life (t1/2) After a Single Dose of Cefiderocol

Timeframe: Up to 8 hours postdose

Terminal Elimination Half-Life (t1/2) After a Minimum of 4 Doses of Cefiderocol

Timeframe: Up to 8 hours postdose

Trial details

NCT IDNCT06086626

SponsorShionogi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-31

View on ClinicalTrials.gov More Gram-Negative Bacterial Infections trials

Who can participate

Age range

3 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Written informed consent has been provided by parent(s) or legally authorized representative(s) in accordance with local regulatory requirements
. Hospitalized infants from birth to \< 3 months (\< 90 days) of age at the time written informed consent is provided. Enrollment of premature infants will not be restricted, but they must have a GA ≥ 26 weeks, PNA of 0 to 3 months, and weight of at least 1 kilogram (kg)
. Require systemic IV antibiotic treatment for suspected or confirmed aerobic Gram-negative infections including, but not limited to, complicated urinary tract infection, complicated intra-abdominal infection, hospital-acquired/ ventilator-associated bacterial pneumonia, and BSI/sepsis
. For the multiple-dose phase, within 72 hours of the start of potentially effective treatment with SOC antibiotics for the suspected or confirmed primary aerobic Gram-negative infection

Exclusion criteria

. Documented history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic
. Life expectancy of \< 72 hours after enrollment
. Urine output \< 1.0 milliliter (mL)/kg/hour within the 24 hours prior to study drug administration on Day 1
. Serum creatinine value greater than the maximum for GA and PNA shown below within the 24 hours prior to study drug administration on Day 1

What they're measuring

Maximum Observed Plasma Concentration (Cmax) After a Single Dose of Cefiderocol

Timeframe: Up to 8 hours postdose

Cmax After a Minimum of 4 Doses of Cefiderocol

Timeframe: Up to 8 hours postdose

Area Under the Concentration-Time Curve Extrapolated From Time 0 to Infinity (AUC0-inf) After Single Dose of Cefiderocol

Timeframe: Up to 8 hours postdose

Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-†) After a Minimum of 4 Doses of Cefiderocol

Timeframe: Up to 3 hours

Terminal Elimination Half-Life (t1/2) After a Single Dose of Cefiderocol

Timeframe: Up to 8 hours postdose

Terminal Elimination Half-Life (t1/2) After a Minimum of 4 Doses of Cefiderocol

Timeframe: Up to 8 hours postdose