Gram-Negative Bacterial InfectionsPhase 2NCT06086626
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants
A Phase 2 study testing Cefiderocol in people with Gram-Negative Bacterial Infections, run by Shionogi at 4 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Gram-Negative Bacterial Infections
- What is being tested?
- Cefiderocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 14 Mar 2024to 31 Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Documented history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic
- Life expectancy of < 72 hours after enrollment
- Urine output < 1.0 milliliter (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 below 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 milligrams per decilieter (mg/dL) (133 micromoles[μmol]/liter [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
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- Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data
- Receiving renal replacement therapy
- Received any other investigational medicinal product within 30 days of study drug administration
- Receiving treatment with a vasopressor at Screening
- 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
- Anticipated need for antibacterial therapy longer than 14 days (example , 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 suspected CNS infection who do not have a lumbar puncture (LP) but who are treated for potential CNS infection, evidence suggestive of CNS infection based on LP results (polymorphonuclear pleocytosis, hypoglycorrhachia, and increased protein concentration), regardless of culture results, LP with organisms on Gram stain or culture-positive cerebrospinal fluid
- Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
Duke University
Durham, North Carolina, 27705
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Taiwan1 site
Chang Gung Memorial Hospital, Linkou Department of Pediatrics
Taoyuan City, 333
About this study
Official title: 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
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.
- Conditions
- Gram-Negative Bacterial Infections
- Being tested
- Cefiderocol, Standard of Care
- Keywords
- Complicated urinary tract infection (cUTI), Complicated intra-abdominal infection (cIAI), Hospital-acquired bacterial pneumonia (HABP), Ventilator-associated (VABP), Bloodstream infection (BSI)/sepsis
- Medical subject headings
- Gram-Negative Bacterial Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefiderocolDrug
Also called S-649266
Administered via intravenous (IV) infusion
Standard of CareDrug
Antibiotics selected by the investigator based on the participant's symptoms, in accordance with local standards
| Study group | Role | What they receive |
|---|---|---|
| Single-Dose Cefiderocol | Experimental | Participants will receive a single dose cefiderocol on Day 1, along with standard of care antibiotics Receives: Drug: Cefiderocol; Drug: Standard of Care |
| Multiple-Dose Cefiderocol | Experimental | Participants will receive cefiderocol every 8 hours for 5 to 14 days, along with standard of care antibiotics Receives: Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) After a Single Dose of Cefiderocol
Measured: Up to 8 hours postdose
Cmax After a Minimum of 4 Doses of Cefiderocol
Measured: Up to 8 hours postdose
Area Under the Concentration-Time Curve Extrapolated From Time 0 to Infinity (AUC0-inf) After Single Dose of Cefiderocol
Measured: Up to 8 hours postdose
Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-†) After a Minimum of 4 Doses of Cefiderocol
Measured: Up to 3 hours
Terminal Elimination Half-Life (t1/2) After a Single Dose of Cefiderocol
Measured: Up to 8 hours postdose
Terminal Elimination Half-Life (t1/2) After a Minimum of 4 Doses of Cefiderocol
Measured: Up to 8 hours postdose
Secondary outcomes (1)
Number of Participants With Adverse Events (AEs)
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start14 Mar 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gram-Negative Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by ShionogiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Shionogi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086626
- Sponsor's protocol ID
- 1904R2136
- Status last verified
- Feb 2026
- First submitted
- 11 Oct 2023
- Last updated
- 2 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bradley JS, Orchiston E, Portsmouth S, Ariyasu M, Baba T, Katsube T, Makinde O. Pharmacokinetics, Safety and Tolerability of Single-dose or Multiple-dose Cefiderocol in Hospitalized Pediatric Patients Three Months to Less Than Eighteen Years Old With Infections Treated With Standard-of-care Antibiotics in the PEDI-CEFI Phase 2 Study. Pediatr Infect Dis J. 2025 Feb 1;44(2):136-142. doi: 10.1097/INF.0000000000004529. Epub 2024 Sep 4.
PubMed 39230271
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06086626
- Acronym / sponsor ID
- 1904R2136
- Conditions
- Gram-Negative Bacterial Infections
- Keywords
- Complicated urinary tract infection (cUTI), Complicated intra-abdominal infection (cIAI), Hospital-acquired bacterial pneumonia (HABP), Ventilator-associated (VABP), Bloodstream infection (BSI)/sepsis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-Dose Cefiderocol | Experimental | Drug: Cefiderocol, Drug: Standard of CareParticipants will receive a single dose cefiderocol on Day 1, along with standard of care antibiotics |
| Multiple-Dose Cefiderocol | Experimental | Drug: Standard of CareParticipants will receive cefiderocol every 8 hours for 5 to 14 days, along with standard of care antibiotics |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- Documented history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic
- Life expectancy of < 72 hours after enrollment
- Urine output < 1.0 milliliter (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 below 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 milligrams per decilieter (mg/dL) (133 micromoles[μmol]/liter [L]) or an increase of 0.3 mg/dL (17 to 27 μmol/L) per day from a previous lower value
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CefiderocolAlso: S-649266Administered via intravenous (IV) infusion | Drug | Single-Dose Cefiderocol |
| Standard of CareAntibiotics selected by the investigator based on the participant's symptoms, in accordance with local standards | Drug | Multiple-Dose Cefiderocol, Single-Dose Cefiderocol |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) After a Single Dose of Cefiderocol
Time frame: Up to 8 hours postdose
Cmax After a Minimum of 4 Doses of Cefiderocol
Time frame: Up to 8 hours postdose
Area Under the Concentration-Time Curve Extrapolated From Time 0 to Infinity (AUC0-inf) After Single Dose of Cefiderocol
Time frame: Up to 8 hours postdose
Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-†) After a Minimum of 4 Doses of Cefiderocol
Time frame: Up to 3 hours
Terminal Elimination Half-Life (t1/2) After a Single Dose of Cefiderocol
Time frame: Up to 8 hours postdose
Terminal Elimination Half-Life (t1/2) After a Minimum of 4 Doses of Cefiderocol
Time frame: Up to 8 hours postdose
1 secondary outcome
Number of Participants With Adverse Events (AEs)
Time frame: Up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Derived from this study: PubMed 39230271Bradley JS, Orchiston E, Portsmouth S, Ariyasu M, Baba T, Katsube T, Makinde O. Pharmacokinetics, Safety and Tolerability of Single-dose or Multiple-dose Cefiderocol in Hospitalized Pediatric Patients Three Months to Less Than Eighteen Years Old With Infections Treated With Standard-of-care Antibiotics in the PEDI-CEFI Phase 2 Study. Pediatr Infect Dis J. 2025 Feb 1;44(2):136-142. doi: 10.1097/INF.0000000000004529. Epub 2024 Sep 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Shionogi
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cefiderocol in people with Gram-Negative Bacterial Infections, run by Shionogi at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, South Africa, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) After a Single Dose of Cefiderocol (time frame: Up to 8 hours postdose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06086626, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.