Cure My Disease

Don't miss your cure!

 Log in / Sign up

New antibiotic shows promise for kids with tough infections

NCT ID NCT04335539

Disease control Sponsor: Shionogi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested the safety and how the body processes the antibiotic cefiderocol in hospitalized children aged 3 months to 18 years with serious bacterial infections. The goal was to see if the drug is safe and how it works in the body. 53 children participated, and the study is now complete.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

53 people

The number who actually took part.

Started

Aug 2020

Finished

Feb 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 months to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participant's parent(s) or legally authorized representative (LAR) provides written informed consent in accordance with regional and country-specific laws and regulations. 2. Participant provides written informed assent, when feasible (age of assent to be determined by institutional review boards/independent ethics committees \[IRB's/IEC's\] or be consistent with local legal requirements). 3. Hospitalized participant is 3 months to \<18 years of age at the time written informed consent/assent is obtained for the single-dose phase. Hospitalized participant is 3 months to \<12 years of age at the time written informed consent/assent is obtained for the multiple-dose phase. Premature babies will not be restricted, but the participant must have an adjusted or postnatal age of 3 months. 4. Participant has a suspected or confirmed infection (including but not limited to complicated urinary tract infection \[cUTI\], complicated intra-abdominal infection \[cIAI\], hospital-acquired pneumonia \[HAP\] /ventilator-acquired pneumonia \[VAP\], sepsis, or bloodstream infections \[BSI\]) that requires hospitalization for treatment with IV antibiotics. 5. If participant is a sexually active female of childbearing potential and has reached menarche or Tanner stage 3, participant agrees to use barrier contraception (including condom, diaphragm, or cervical cap) with spermicide or agrees to use a highly effective method of contraception (including contraceptive implant, injectable contraceptive, combination oral contraceptive, or an intrauterine \[IUD\] contraceptive device) from Screening up to 28 days after administration of the last dose of cefiderocol. Exclusion Criteria: 1. Participant has a documented history of any hypersensitivity or allergic reaction to any β-lactam antibiotic (Note: for β-lactams, a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment). 2. Multiple-dose only: Participant has an infection caused only by a confirmed Gram-positive pathogen. 3. Participant has a suspected or confirmed central nervous system (CNS) infection (eg, meningitis, brain abscess, shunt infection) or osteomyelitis (which would require prolonged antibiotic therapy). 4. Participant has cystic fibrosis. 5. Single-dose phase: Participant has moderate or severe renal impairment based on estimated glomerular filtration rate (eGFR) (based on Schwartz equation if ≥ 3 months to \< 1 year of age and modified Bedside Schwartz equation if ≥ 1 to \< 18 years of age) of \< 60 milliliter (mL) per minute (min)/1.73 \^2² at Screening. Multiple-dose phase: Participant has an eGFR (based on Schwartz equation if ≥ 3 months to \< 1 year of age and modified Bedside Schwartz equation if ≥ 1 to \< 18 years of age) of \< 15 mL/min/1.73 \^2² at Screening. 6. Participant has end-stage renal disease (ESRD), is on hemodialysis (HD), or receiving continuous venovenous hemofiltration (CVVH). 7. Participant has experienced shock in the prior month or is in shock at the time of Screening. 8. Participant has severe neutropenia or is severely immunocompromised. 9. Participant has multiorgan failure. 10. Participant has a life expectancy of \< 30 days due to severity of a concurrent illness. 11. Participant is a female who has a positive pregnancy test at Screening. 12. Participant is a female who is breastfeeding. 13. Participant has received any other investigational medicinal product (IMP) within 30 days. 14. Participant has 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, including acute trauma to the pelvis or urinary tract. 15. Participant is receiving vasopressor therapy at Screening.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Bloodstream infections (BSI) are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

bacterial infectious disease with sepsis bacterial urinary tract infection gram-negative bacterial infections Healthcare-Associated Pneumonia infectious disease with sepsis infectious peritonitis nosocomial infection Pneumonia, Ventilator-Associated Sepsis urinary tract infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bloodstream infections (BSI) Complicated intra-abdominal infection (CIAI) Complicated urinary tract infection (CUTI) Gram-negative bacterial infections Hospital acquired pneumonia (HAP) Sepsis Ventilator acquired pneumonia

Contacts and locations

Locations

  • Bernu Kliniska Universitates Slimnica Childrens Hospital - Tornakalna

    Riga, Latvia

  • Cliniques Universitaires Saint-Luc

    Brussels, Belgium

  • Daugavpils regional Hospital

    Daugavpils, Latvia

  • Dnipropetrovsk Regional Children Clinical Hospital

    Kharkiv, Ukraine

  • Heim Pl Orszgos Gyermekgygyszati Intzet

    Pilisborosjenő, Hungary

  • Higher State Educational Institute of Ukraine Ukrainian Medical Stamatological Academy

    Poltava, Ukraine

  • Hospital Germans Trias i Pujol

    Barcelona, Spain

  • Hospital Universitario y Politecnico La Fe

    Valencia, Spain

  • JSC "EVEX Medical Corporation"- M Lashvili Childrens Central Hospital

    Tbilisi, Georgia

  • JSC "Medical Corporation Evex" " M. Iashvili Batumi Maternal and Child Central Hospital"

    Batumi, Georgia

  • Khon Kaen University (KKU) - Faculty of Medicine-Srinagarind Hospital

    Khon Kaen, Thailand

  • King Chulalongkorn Memorial Hospital, Chulalongkorn University

    Bangkok, Thailand

  • Ltd Unimedi Kakheti Childrens New Clinic

    Tbilisi, Georgia

  • National Childrens Specialized Hospital OHMATDYT of the Ministry of Health of Ukraine

    Kiev, Ukraine

  • PHPT-Chiangrai PrachanuKroh Hospital

    Chiang Mai, Thailand

  • Regional Children Clinical Hospital

    Kharkiv, Ukraine

  • Siriraj Hospital

    Bangkok Noi, Thailand

  • Smolensk State Medical University

    Smolensk, Russia

  • St. Petersburg State Pediatric Medical University

    Saint Petersburg, Russia

  • Szegedi Tudomnyegyetem

    Szegedi Tudomnyegyetem, Hungary

  • Tallinn Childrens Hospital

    Tallinn, Estonia

  • Tartu Ulikooli Kliinikum - Anestesioloogia ja Intensiivravi Kliinik

    Tartu, Estonia

  • Universitair Ziekenhuis Brussel

    Brussels, 1200, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.