A multicenter, single-arm, open-label study to assess the pharmacokinetics, safety, and tolerability of cefiderocol in hospitalized pediatric patients from birth to < 3 months of age with suspected or confirmed aerobic Gram-negative bacterial infections - 1904R2136

Shionogi B.V.0 sites40 target enrollmentJune 30, 2023

ConditionsAerobic Gram-negative bacterial infections Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Aerobic Gram-negative bacterial infections
Sponsor: Shionogi B.V.
Enrollment: 40
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 30, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Shionogi B.V.

Eligibility Criteria

Inclusion Criteria

•Written informed consent has been provided by parent(s) or legally authorized representative(s) (LAR) 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 kg., Require systemic IV antibiotic treatment for suspected or confirmed aerobic Gram\-negative infections, including but not limited to, cUTI, cIAI, HABP/VABP, 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 Gramnegative infection

Exclusion Criteria

•Documented history of any moderate or severe hypersensitivity or allergic reaction to any ß\-lactam antibiotic (Note: for ß\-lactams, a history of a mild rash followed by uneventful re\-exposure is not a contraindication to enrollment), Receiving treatment with a vasopressor at Screening, Confirmed or strongly suspected infection at Screening with a pathogen known to be resistant to cefiderocol or only a Gram\-positive pathogen or viral, fungal, or parasitic pathogen as the sole cause of infection, Anticipated need for antibacterial therapy longer than 14 days (eg, osteomyelitis or endocarditis); this applies to both study treatment with cefiderocol, as well as adjunctive IV antibacterial treatment for suspected coinfection with Gram\-positive organisms or multidrug resistant Gram\-negative organisms, Suspected or confirmed central nervous system (CNS) infection, including patients with suspected CNS infection who do not have a lumbar puncture (LP) but who are treated for potential CNS infection, patients who have evidence suggestive of CNS infection based on LP results (polymorphonuclear pleocytosis, hypoglycorrhachia, and increased protein concentration), regardless of culture results, and patients with a LP with organisms on Gram stain or culture\-positive CSF, Life expectancy of \< 72 hours after enrollment, Urine output \< 1\.0 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 in the Protocol 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 mg/dL (133 µmol/L) or an increase of 0\.3 mg/dL (17 to 27 µmol/L) per day from a previous lower value, 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 patient or the quality of the study data, Receiving renal replacement therapy, Received any other investigational medicinal product within 30 days of study drug administration