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Anti-bacterial agent

Cefiderocol for Bacterial Infections in Newborns and Infants

Q: Is Single-Dose Cefiderocol a viable option for safe patient treatment?

Given the limited amount of clinical data on Single-Dose Cefiderocol's efficacy, its safety was assessed as a 2.

Q: Are there any vacancies currently available for participants in this experiment?

According to the information hosted on clinicaltrials.gov, this research is actively enrolling patients. The trial was initially published on October 31st 2023 and has since been updated as of October 30th 2023.

Q: What is the participant count for this clinical experiment?

Affirmative. As per the clinicaltrials.gov website, this medical study is presently enrolling participants and was initially made available on October 31st 2023. The most current update to the trial occurred on October 30th 2023; 40 individuals are being sought at 1 site.

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

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

Select...

I need IV antibiotics for a serious bacterial infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Cmax After a Minimum of 4 Doses of Cefiderocol

+3 more

Secondary outcome measures

Number of Participants With Adverse Events (AEs)

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

~1800

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

ShionogiLead Sponsor

116 Previous Clinical Trials

41,446 Total Patients Enrolled

Medical DirectorStudy DirectorShionogi

2,777 Previous Clinical Trials

8,064,364 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Single-Dose Cefiderocol a viable option for safe patient treatment?

"Given the limited amount of clinical data on Single-Dose Cefiderocol's efficacy, its safety was assessed as a 2."

Answered by AI

Are there any vacancies currently available for participants in this experiment?

"According to the information hosted on clinicaltrials.gov, this research is actively enrolling patients. The trial was initially published on October 31st 2023 and has since been updated as of October 30th 2023."

Answered by AI

What is the participant count for this clinical experiment?

"Affirmative. As per the clinicaltrials.gov website, this medical study is presently enrolling participants and was initially made available on October 31st 2023. The most current update to the trial occurred on October 30th 2023; 40 individuals are being sought at 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06086626.