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Anti-bacterial agent

Cefiderocol for Bacterial Infections in Newborns and Infants

Phase 2
Recruiting
Research Sponsored by Shionogi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
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)
Must not have
Has a 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
Receiving renal replacement therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial studies the effectiveness of cefiderocol in treating bacterial infections in newborns & babies under 3 months.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects for neonates aren't detailed here, common side effects of antibiotics like Cefiderocol may include allergic reactions, gastrointestinal discomfort (like diarrhea), potential kidney function impact, and possible interactions with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I started antibiotics for a bacterial infection less than 72 hours ago.
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My infant is hospitalized, under 3 months old, weighs at least 1kg, and was born after at least 26 weeks of pregnancy.
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I need IV antibiotics for a serious bacterial infection.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an infection resistant to certain antibiotics or caused only by a specific type of germ.
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I am on dialysis.
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I am currently on medication to raise my blood pressure.
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I expect to need antibiotics for more than 14 days for a condition like bone or heart infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Single-Dose CefiderocolExperimental Treatment2 Interventions
Participants will receive a single dose cefiderocol on Day 1, along with standard of care antibiotics
Group II: Multiple-Dose CefiderocolExperimental Treatment1 Intervention
Participants will receive cefiderocol every 8 hours for 5 to 14 days, along with standard of care antibiotics
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard of Care
2017
Completed Phase 4
~4420
Cefiderocol
2020
Completed Phase 3
~1890

Find a Location

Who is running the clinical trial?

ShionogiLead Sponsor
116 Previous Clinical Trials
41,445 Total Patients Enrolled
Medical DirectorStudy DirectorShionogi
2,891 Previous Clinical Trials
8,089,234 Total Patients Enrolled
~4 spots leftby Dec 2024
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