Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT04215991 · ClinicalTrials.gov registry record · Phase 2

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants

A Phase 2 study of Gram-negative Bacterial Infections and Hospital Acquired Bacterial Pneumonia (HABP), sponsored by Shionogi.

Completed
Registry status
Phase 2
Development phase
91
Enrollment target
20
Study locations

NCT04215991 is a Phase 2 study of Gram-negative Bacterial Infections and Hospital Acquired Bacterial Pneumonia (HABP) that has completed, run by Shionogi. The registered enrollment target is 91 participants, below the 420-participant average among 4 other Gram-negative Bacterial Infections trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 7 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT04215991, a Phase 2 study of Gram-negative Bacterial Infections and Hospital Acquired Bacterial Pneumonia (HABP), has completed, sponsored by Shionogi.

COMPLETED
Registry status
Phase 2
Development phase
91 participants
Enrollment target
20
Study locations

Study Summary

The primary objectives of this study are to assess the safety, tolerability, and pharmacokinetics (PK) of cefiderocol after single-dose administration in hospitalized pediatric participants 3 months to \< 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections and after multiple-dose administration in hospitalized pediatric participants 3 months to \< 18 years of age with suspected or confirmed complicated urinary tract infection (cUTI), hospital-acquired bacterial pneumonia (HABP), or ventilator-associated bacterial pneumonia (VABP).

Conditions Studied

Gram-negative Bacterial Infections Hospital Acquired Bacterial Pneumonia (HABP) Complicated Urinary Tract Infection (cUTI) Ventilator Associated Bacterial Pneumonia (VABP)

Interventions

  • DRUG Standard of Care
  • DRUG Cefiderocol

Study Locations (20)

Other

  • JSC "EVEX Medical Corporation"- M Lashvili Childrens Central Hospital - Tbilisi
  • Ltd Unimedi Kakheti Childrens New Clinic - Tbilisi
  • University Hospital "ATTIKON" 3rd Pediatric Clinic of NKUA - Chaïdári
  • Hippokration Hospital 3rd Pediatric Clinic of AUTH Konstantinoupoleos 49 - Thessaloniki
  • General Hospital of Thessaloniki Papageorgiou - Thessaloniki
  • Hospital of Lithuanian University of Health Sciences Kauno klinikos - Kaunas
  • Klaipeda Children's Hospital - Klaipėda
  • Vilnius University Hospital Santaros Klinikos - Vilnius
  • Instituto Nacional de Pediatría "Laboratorio de la Unidad de Apoyo a la Investigación Clínica", Planta Baja Col. Insurgentes Cuicuilco, Delegacion Coyoacán Av. Insurgentes Sur 3700-C - Mexico City
  • Hospital de Especialidades Ped Via España y Calle Zarak - Panama City
  • Hospital del Niño, Epidemiologia - Panama City
  • Chong Hua Hospital - Cebu City
  • Western Visayas and Medical Center - Iloilo City
  • Manila Doctor's Hospital - Manila

Iowa

  • University of Iowa Stead Family Children's Hospital - Iowa City

Texas

  • Cook Children's Medical Center - Fort Worth

Queensland

  • Queensland Children's Health Precinct Level 8, Centre for Children's Health Research 62 Graham Street - South Brisbane

Crete

  • Heraklion University General Hospital - Heraklion

Thessaly

  • University General Hospital of Larissa - Larissa

Jalisco

  • Hospital Civil de Guadalajara Hospital 278, El retiro, Torre Piso 10, Infectología Ped. - Guadalajara

Trial Details

FieldValue
Enrollment Target 91 participants
Start Date 2020-02-19
Est. Completion 2024-09-17
Phase Phase 2

Sponsor

Shionogi

54 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04215991

The ClinicalTrials.gov registry entry for NCT04215991 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 91 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 420-participant average among 4 other Gram-negative Bacterial Infections trials with a reported enrollment target (78% lower). The listed sponsor is Shionogi, which has 54 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Gram-negative Bacterial Infections appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.

NCT04215991 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Other, Iowa, Texas.

Frequently Asked Questions

What is clinical trial NCT04215991 about?

NCT04215991 is a clinical study titled "A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants". The primary objectives of this study are to assess the safety, tolerability, and pharmacokinetics (PK) of cefiderocol after single-dose administration in hospitalized pediatric participants 3 months to \< 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections and afte...

What is the current status of trial NCT04215991?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2020-02-19. Estimated completion is 2024-09-17.

What conditions does trial NCT04215991 study?

This clinical trial studies the following conditions: Gram-negative Bacterial Infections, Hospital Acquired Bacterial Pneumonia (HABP), Complicated Urinary Tract Infection (cUTI), Ventilator Associated Bacterial Pneumonia (VABP).

What interventions are being tested in trial NCT04215991?

The interventions under investigation include: Standard of Care (DRUG), Cefiderocol (DRUG).

Who is sponsoring clinical trial NCT04215991?

This trial is sponsored by Shionogi, which has 54 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04215991 being conducted?

This trial has 20 study locations across Iowa, Texas, Queensland, Crete, Thessaly. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Gram-negative Bacterial Infections

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Gram-negative Bacterial Infections

All registered trials for this condition

Hospital Acquired Bacterial Pneumonia (HABP)

All registered trials for this condition

Iowa

All trials with a study site in Iowa

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.