Cefiderocol for Bacterial Infections in Newborns and Infants

Recruiting at 3 trial locations

Overseen By Shionogi Clinical Trials Administrator Clinical Support Help Line

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Shionogi

Must be taking: Systemic IV antibiotics

Must not be taking: Vasopressors, others

Disqualifiers: Hypersensitivity to β-lactams, AKI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5-14 days

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Medical Director

Principal Investigator

Shionogi

Eligibility Criteria

This trial is for hospitalized infants from birth to less than 3 months old with suspected or confirmed aerobic Gram-negative bacterial infections. They must weigh at least 1 kg and can be premature as long as they are over 26 weeks gestational age. Infants with severe allergies to β-lactam antibiotics, kidney issues, or those needing treatment longer than 14 days for certain conditions cannot participate.

Inclusion Criteria

I started antibiotics for a bacterial infection less than 72 hours ago.

My infant is hospitalized, under 3 months old, weighs at least 1kg, and was born after at least 26 weeks of pregnancy.

My guardian has given written permission for me to participate.

Exclusion Criteria

Urine output < 1.0 milliliter (mL)/kg/hour within the 24 hours prior to study drug administration on Day 1

Received any other investigational medicinal product within 30 days of study drug administration

I have an infection resistant to certain antibiotics or caused only by a specific type of germ.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either a single dose or multiple doses of cefiderocol along with standard of care antibiotics

5-14 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cefiderocol

Trial Overview The study is testing the safety and how the body processes Cefiderocol, an antibiotic, in newborns and young infants when given once or multiple times. It compares this new treatment against the standard care usually provided for these types of infections.

Participant Groups

Group I: Single-Dose Cefiderocol Experimental Treatment 2 Interventions

Participants will receive a single dose cefiderocol on Day 1, along with standard of care antibiotics

Group II: Multiple-Dose Cefiderocol Experimental Treatment 1 Intervention

Participants will receive cefiderocol every 8 hours for 5 to 14 days, along with standard of care antibiotics

Who Is Running the Clinical Trial?

Shionogi

Lead Sponsor

Trials

122

Recruited

42,100+

Dr. Isao Teshirogi

Shionogi

Chief Executive Officer since 2008

PhD in Pharmaceutical Sciences from the University of Tokyo

Dr. Takuko Sawada

Shionogi

Chief Medical Officer since 2022

MD from a recognized institution (specific details not found)