Cefiderocol for Bacterial Infections in Newborns and Infants

No longer recruiting at 4 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how cefiderocol, a new antibiotic, works in newborns and infants under 3 months old with suspected or confirmed bacterial infections caused by aerobic Gram-negative bacteria. Researchers aim to understand how the drug moves through and affects the body with single and multiple doses. The trial includes two groups: one receives a single dose, while the other receives doses every 8 hours over several days. It seeks babies in the hospital who need IV antibiotics for serious bacterial infections like pneumonia or sepsis. Babies with a history of allergic reactions to certain antibiotics or severe kidney issues are not suitable for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important medical advancements.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if participants must stop taking their current medications. However, it mentions that participants should not have received any other investigational medicinal product within 30 days of the study drug administration.

Is there any evidence suggesting that cefiderocol is likely to be safe for newborns and infants?

Research shows that cefiderocol is generally safe for people. In earlier studies, when participants took cefiderocol either once or over several days, only a few unexpected medical issues arose. Importantly, the treatment did not cause these issues. This indicates that cefiderocol is safe to use and well-tolerated, even for up to 14 days.

Moreover, cefiderocol is already approved for adults with certain bacterial infections, supporting its safety. This approval means the drug has passed strict safety tests for other conditions, which bodes well for its use in newborns and infants. However, ongoing trials will confirm its safety for these younger age groups. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Cefiderocol is unique because it targets hard-to-treat bacterial infections with a novel mechanism: it acts like a Trojan horse, using the bacteria's own iron transport system to penetrate and kill it from the inside. Unlike standard antibiotics for newborns and infants, which often face resistance issues, cefiderocol shows promise against multidrug-resistant strains. Researchers are excited about its dual dosing regimen—either a single dose or multiple doses—because it offers flexibility and potential for quicker, more effective treatment outcomes.

What evidence suggests that cefiderocol could be an effective treatment for bacterial infections in newborns and infants?

Research has shown that cefiderocol works well against certain bacterial infections. In one instance, a newborn who received cefiderocol, along with other antibiotics, fully recovered from a severe infection. Studies have found that cefiderocol fights resistant bacteria by attaching to iron, which bacteria need to live. Although it has been successful in some cases, one study found it wasn't better than regular antibiotics at reducing deaths. Overall, cefiderocol seems promising, especially for hard-to-treat infections, but more research is needed to confirm its effectiveness in newborns and infants. Participants in this trial will receive either a single dose or multiple doses of cefiderocol, alongside standard care antibiotics, to evaluate its effectiveness in this population. ^{2 3 4 6 7}

Who Is on the Research Team?

Medical Director

Principal Investigator

Shionogi

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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)

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11731048/

Pharmacokinetics, Safety and Tolerability of Single-dose or ... Cefiderocol was well tolerated in both the single-dose and multiple-dose phases of the study, with infrequent AEs, none of which were related to ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06086626

NCT06086626 | A Study to Assess the Safety, Tolerability ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12137400/

Successful therapy of a newborn with Stenotrophomonas ... The total 2-week treatment with cefiderocol plus TMP/SMX and tigecycline led to clinical and microbiological cure. On day 70, the baby was ...

4. clinicaltrials.eu clinicaltrials.eu/trial/study-on-cefiderocol-for-treating-gram-negative-bacterial-infections-in-hospitalized-infants-under-3-months/

Study on Cefiderocol for Treating Gram-negative Bacterial ... This study investigates the safety and efficacy of the antibiotic cefiderocol in treating aerobic Gram-negative bacterial infections in ...

5. cidrap.umn.edu cidrap.umn.edu/antimicrobial-stewardship/trial-finds-cefiderocol-isnt-superior-standard-antibiotics-bloodstream

Trial finds cefiderocol isn't superior to standard antibiotics ... At 14 days, 20 (8%) of 250 patients in the cefiderocol group had died, compared with 17 (7%) of 254 patients in the standard-of-care group, for ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39230271/

Pharmacokinetics, Safety and Tolerability of Single-dose or ... Conclusions: Multiple-dose cefiderocol, administered for 5-14 days and according to body weight, achieved steady-state plasma concentrations ...

7. gardp.org gardp.org/neonatal-sepsis/

Neonatal sepsis | GARDP 1 in 5 deaths caused by antibiotic resistance occur in children under the age of five, and up to 3 million newborns get serious infections that lead to sepsis ...