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

Sepsis Clinical Trial

Official title:
A Single Arm, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Paediatric Subjects 3 Months to <18 Years of Age With Suspected or Confirmed Aerobic Gram-negative Bacterial Infections

Status Completed

Clinical Trial Summary

The primary objectives of this study are: - To assess the safety and tolerability of cefiderocol after single-dose administration in hospitalized paediatric participants 3 months to < 18 years of age with suspected or confirmed aerobic Gram-negative bacterial infections - To assess the pharmacokinetics (PK) of cefiderocol after single-dose administration of cefiderocol in hospitalized paediatric participants 3 months to < 18 years of age with suspected or confirmed aerobic Gram-negative bacterial infections - To assess the safety and tolerability of cefiderocol after multiple-dose administration in hospitalized paediatric participants 3 months to < 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections - To assess the PK of cefiderocol after multiple-dose administration in hospitalized paediatric participants 3 months to < 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections

Clinical Trial Description

This is a multicenter, single-arm, open-label, single- and multiple-dose study to assess the safety, tolerability, and PK of cefiderocol in hospitalized paediatric participants. The single-dose phase will include 4 separate cohorts of participants, grouped according to age range: - Cohort 1: 12 to < 18 years - Cohort 2: 6 to < 12 years - Cohort 3: 2 to < 6 years - Cohort 4: 3 months to < 2 years Cohorts 1, 2, and 3 in the single-dose phase will be initiated in parallel. Cohort 4 will begin after safety and PK data from at least 6 participants from the single-dose Cohorts 1, 2, and 3 (with a minimum of 3 participants from Cohort 3) have been assessed. The multiple-dose phase will include 3 cohorts according to age range (Cohorts 2, 3, and 4) and will begin after safety and PK data from 6 participants in the corresponding single-dose cohort have been assessed. ;

Study Design

Related Conditions & MeSH terms

Bacterial Infections
Bloodstream Infections (BSI)
Communicable Diseases
Complicated Intra-abdominal Infection (cIAI)
Complicated Urinary Tract Infection (cUTI)
Gram-negative Bacterial Infections
Healthcare-Associated Pneumonia
Hospital Acquired Pneumonia (HAP)
Infections
Intraabdominal Infections
Pneumonia
Pneumonia, Ventilator-Associated
Sepsis
Urinary Tract Infections
Ventilator-acquired Pneumonia

Clinical Trial Details

NCT number	NCT04335539
Study type	Interventional
Source	Shionogi Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	August 21, 2020
Completion date	February 6, 2023

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05095324` - The Biomarker Prediction Model of Septic Risk in Infected Patients
Completed	`NCT02714595` - Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens	Phase 3
Completed	`NCT03644030` - Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
Completed	`NCT02867267` - The Efficacy and Safety of Ta1 for Sepsis	Phase 3
Completed	`NCT04804306` - Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
Recruiting	`NCT05578196` - Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections.	N/A
Terminated	`NCT04117568` - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Completed	`NCT03550794` - Thiamine as a Renal Protective Agent in Septic Shock	Phase 2
Completed	`NCT04332861` - Evaluation of Infection in Obstructing Urolithiasis
Completed	`NCT04227652` - Control of Fever in Septic Patients	N/A
Enrolling by invitation	`NCT05052203` - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
Terminated	`NCT03335124` - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock	Phase 4
Recruiting	`NCT04005001` - Machine Learning Sepsis Alert Notification Using Clinical Data	Phase 2
Completed	`NCT03258684` - Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock	N/A
Recruiting	`NCT05217836` - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Completed	`NCT05018546` - Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery	N/A
Completed	`NCT03295825` - Heparin Binding Protein in Early Sepsis Diagnosis	N/A
Not yet recruiting	`NCT06045130` - PUFAs in Preterm Infants
Not yet recruiting	`NCT05361135` - 18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia	N/A
Not yet recruiting	`NCT05443854` - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01)	Phase 3