A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized N… (NCT06086626) | Clinical Trial Compass
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 range3 Months
SexALL
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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
✕. Neonatal acute kidney injury (AKI), defined as a serum creatinine level greater than 1.5 milligrams per decilieter (mg/dL) (133 micromoles\[μmol\]/liter \[L\]) or an increase of 0.3 mg/dL (17 to 27 μmol/L) per day from a previous lower value
What they're measuring
1
Maximum Observed Plasma Concentration (Cmax) After a Single Dose of Cefiderocol
Timeframe: Up to 8 hours postdose
2
Cmax After a Minimum of 4 Doses of Cefiderocol
Timeframe: Up to 8 hours postdose
3
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
4
Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-†) After a Minimum of 4 Doses of Cefiderocol
Timeframe: Up to 3 hours
5
Terminal Elimination Half-Life (t1/2) After a Single Dose of Cefiderocol
Timeframe: Up to 8 hours postdose
6
Terminal Elimination Half-Life (t1/2) After a Minimum of 4 Doses of Cefiderocol
✕. Acute kidney injury based on an increase in serum creatinine ≥ 0.3 mg/dL within 48 hours from an established baseline value
✕. Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data