Clinical trials: Pediatric Sepsis
Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia
Xylitol Dental Wipes for the Reduction of Bloodstream Infection Risk in Children With Acute Myeloid Leukemia
This phase III trial compares the effect of xylitol dental wipes to dental wipes without xylitol for the reduction of bloodstream infection in children with acute myeloid leukemia (AML).
- Trial name
- NCT07022678
- Testing
- Best Practice, Biospecimen Collection, Cytarabine
- Where
- 39 sites in United States
- Volunteers
- 556 people
- Sponsor
- Children's Oncology Group
Newborn Sepsis, Fever
Interest of the Presepsin Assay as a Biomarker of Bacterial Infection, in the Management of Newborns and Infants Under 3 Months of Age Admitted for Fever in Pediatric Emergency Service (Presepsin)
The purpose of this study is to validate presepsin as a biological marker for identifying bacterial fever among febrile syndromes of infants under three months of age.
- Trial name
- presepsin (NCT04076345)
- Testing
- Prespesin assay on PATHFAST analyser
- Where
- France
- Volunteers
- 31 people
- Sponsor
- University Hospital, Clermont-Ferrand
Systemic Infections
Safety and Tolerability of Ceftazidime-Avibactam for Pediatric Patients With Suspected or Confirmed Infections
To assess the pharmacokinetics, safety and tolerability of a single dose of CAZ-AVI in children from 3 months of age to <18 years.
- Trial name
- NCT01893346
- Testing
- CAZ-AVI
- Where
- 10 sites in United States
- Volunteers
- 35 people
- Sponsor
- Pfizer
Sepsis
Neutrophil Extracellular Traps and Neonatal (PV4991) & Pediatric Sepsis (PV5063)
This study is designed to assess the role of neutrophil extracellular traps (NETs) in neonatal and pediatric sepsis as well as to evaluate markers of NETs formation as early predictors of neonatal and pediatric sepsis.
- Trial name
- NCT02567305
- Testing
- Markers of NET formation
- Where
- 2 sites in Germany
- Volunteers
- 200 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Sepsis
Impact of Blood Culture Positivity Time on Clinical Management of Pediatric ICU Patients
Sepsis accounts for high morbidity and mortality rates in ICU globally. Early recognition of sepsis with appropriate antimicrobial therapy is critical for the appropriate management of patients (1).
- Trial name
- NCT05507957
- Testing
- direct reporting of time to positivity of blood culture to ICU to know its effect to patients managment
- Where
- Egypt
- Volunteers
- 120 people
- Sponsor
- Assiut University
Sepsis, Sepsis Bacterial
Molecular Culture for the Diagnosis of Pediatric Sepsis
Babies and children have an increased risk of getting an infection with a bacteria in the bloodstream (sepsis). It is often difficult for the doctor to determine whether a child has an infection of the bloodstream, because the…
- Conditions
- Sepsis, Sepsis Bacterial, Sepsis, Neonatal, Infection, Bacterial
- Trial name
- CHAMPIONS (NCT06018792)
- Testing
- Molecular Culture
- Where
- 2 sites in Netherlands
- Volunteers
- 1,835 people
- Sponsor
- Jip Groen
Shock, Sepsis
Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO
The purpose of this study is To assess the value of dynamics (SVV, PPV) and static indices (GEDVI, ITBVI, CVP) of preload and its combination with contractility (CI,SV, ventricular power, dP/dtmax, CFI, GEF) and lung water…
- Conditions
- Shock, Sepsis, Systemic Inflammatory Response Syndrome, Low Cardiac Output
- Trial name
- PreloaDren (NCT01157299)
- Where
- 7 sites in Spain
- Volunteers
- 100 people
- Sponsor
- Hospital Universitario La Paz
Sepsis, Sepsis Mrsa
Reducing Empiric VAncomycin Use in Pediatric Suspected Sepsis
The goal of this quasi-experimental interventional study is to determine the effectiveness of a multifaceted stewardship intervention in reducing overall vancomycin use in five tertiary care Pediatric Intensive Care Units (PICU).
- Conditions
- Sepsis, Sepsis Mrsa, Sepsis Bacteremia, Antimicrobial - Induced Nephropathy
- Trial name
- REVAMP (NCT05975671)
- Testing
- Multifaceted de-implementation strategy to reduce vancomycin overuse
- Where
- 4 sites in United States
- Volunteers
- 52,500 people
- Sponsor
- Children's Hospital of Philadelphia
Central Line Complication, Central Line Infection
Innovative Central Line Securement Device in the Pediatric Population
This study involves evaluating pediatric patients with central lines to determine differences in line complications and quality of life in those with a novel central line securement device (wrap) as compared to those who use a…
- Conditions
- Central Line Complication, Central Line Infection, Central Line-Associated Infection, Central Line Sepsis
- Trial name
- NCT04522778
- Testing
- Wearable Central Line Securement Device (Vest), Traditional Securement Dressing
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Ryan St. Pierre-Hetz
Gram-negative Bacterial Infections, Bloodstream Infections (BSI)
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants
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…
- Conditions
- Gram-negative Bacterial Infections, Bloodstream Infections (BSI), Complicated Intra-abdominal Infection (cIAI), Hospital Acquired Pneumonia (HAP)
- Trial name
- NCT04335539
- Testing
- Cefiderocol, Standard of Care
- Where
- 23 sites in Belgium, Estonia and 7 more
- Volunteers
- 53 people
- Sponsor
- Shionogi
Acute Kidney Injury, Acute Kidney Injury Due to Sepsis
QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry
QUELIMMUNE is FDA-approved under an HDE for the treatment of pediatric patients (weight ≥10kg and age ≤22 years) with AKI due to sepsis or a septic condition on antibiotic therapy and requiring RRT.
- Trial name
- SAVE (NCT06517810)
- Testing
- QUELIMMUNE (SCD-PED)
- Where
- 15 sites in United States
- Volunteers
- 50 people
- Sponsor
- SeaStar Medical
Pediatric Cancer
Care Bundle Containing Chlorhexidine Dressing on Port Catheter and Central Venous Catheters
In order to provide treatment in pediatric hematology-oncology patients, in some cases a central venous catheter is required in children.
- Trial name
- CHG-port (NCT06720064)
- Testing
- Chlorhexidine Dressing
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people
- Sponsor
- Dokuz Eylul University
Acute Kidney Injury, Chronic Kidney Disease
Long Term Impact of Pediatric Acute Renal Injury in Severe Sepsis
Sepsis is the most common cause of childhood death worldwide. Millions of children survive, but are left with impaired health. Sepsis-related Acute Kidney Injury (sAKI) is increasingly recognized as a significant factor…
- Conditions
- Acute Kidney Injury, Chronic Kidney Disease, Hypertension
- Trial name
- IMPRESS (NCT02372721)
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Florida
Septic Shock
Stress Hydrocortisone In Pediatric Septic Shock
SHIPSS is a multi-institutional, prospective, controlled, randomized, double-blinded interventional trial that will examine the potential benefits and risks of adjunctive hydrocortisone prescribed for children with fluid and…
- Trial name
- SHIPSS (NCT03401398)
- Testing
- Hydrocortisone, sodium succinate, Normal saline
- Where
- 44 sites in United States, Brazil and 8 more
- Volunteers
- 500 people
- Sponsor
- Jerry Zimmerman
Sepsis
Evaluation of Corticosteroid Therapy in Childhood Severe Sepsis - a Randomised Pilot Study
Severe bacterial infections affecting multiple body organs, called severe sepsis (including meningococcal sepsis), remain an important cause of death and disability among children.
- Trial name
- StePS (NCT00732277)
- Testing
- hydrocortisone
- Where
- 3 sites in United Kingdom
- Volunteers
- 21 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Gram-Positive Bacterial Infections, Vancomycin
Clinical Decision Support Tool for Vancomycin Dosing in Children
This study will evaluate the pharmacokinetic and pharmacodynamic dosing properties of intravenous vancomycin in pediatric patients using a novel computer decision support (CDS) tool called Lyv.
- Conditions
- Gram-Positive Bacterial Infections, Vancomycin, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT04911270
- Testing
- Computer Decision Support Tool Intervention Group, Matched Historical Controls
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- University of Maryland, Baltimore
Sepsis
Efficacy of Betalactam Antibiotics in Prolonged Infusion Compared to Intermittent in Pediatric Patients With Sepsis
This study evaluates the efficacy and safety of the administration of betalactam antibiotics in prolonged infusion compared to intermittent infusion in children with sepsis.
- Trial name
- NCT03019965
- Testing
- Intermittent Piperacillin/tazobactam, Continuous Piperacillin/tazobactam, Intermittent Imipenem
- Where
- 2 sites in Mexico
- Volunteers
- 426 people
- Sponsor
- Coordinación de Investigación en Salud, Mexico
Sepsis
Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis
The purposes of this study are to determine: 1. Whether drotrecogin alfa (activated) helps children with severe sepsis survive their condition more often or recover faster than children who do not receive drotrecogin alfa…
- Trial name
- NCT00049764
- Testing
- Drotrecogin alfa (activated)
- Where
- 49 sites in United States, Australia and 9 more
- Volunteers
- 474 people
- Sponsor
- Eli Lilly and Company
Bloodstream Infection, Bacteremia Sepsis
Oral Switch in Pediatric Bloodstream Infections
This nationwide, multicenter, randomized, non-inferiority trial of children and adolescents with uncomplicated bloodstream infections aims to investigate if early-oral antibiotic switch (experimental arm) is non-inferior to…
- Trial name
- Oral_Switch (NCT07791914)
- Testing
- Oral antibiotic therapy, Standard IV antibiotic therapy
- Where
- 18 sites in Denmark
- Volunteers
- 150 people
- Sponsor
- Ulrikka Nygaard
Central Line Complication, Central Line-associated Bloodstream Infection (CLABSI)
Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
In this research study we want to learn more about a study drug, tetrasodium sodium EDTA (Kitelock™) for maintaining the patency (blood flow) through a central venous catheter.
- Trial name
- NCT04559334
- Testing
- Tetrasodium EDTA Catheter Lock Solution
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Boston Children's Hospital