Clinical trials: Pediatric Sepsis
Bacteremia
Safety & Efficacy of Daptomycin Versus Standard of Care (SOC) in 1 - 17 Year Olds With Staphylococcus Aureus Bacteremia (MK-3009-005)
The intent of this study is to describe the safety and efficacy of daptomycin versus standard of care (SOC) in pediatric participants aged 1-17 years with bacteremia caused by Staphylococcus aureus (S. aureus).
- Trial name
- NCT01728376
- Testing
- Daptomycin, Comparator
- Volunteers
- 82 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Central Line Associated Bloodstream Infections (CLABSI), Bone Marrow Transplant
Parafilm to Prevent CLABSI in Pediatric Patients Undergoing HCT
The purpose of this study is to see if applying parafilm as an external barrier on the central line in children having a bone marrow transplant helps to prevent central line associated bloodstream infection(s) and also to assess…
- Trial name
- NCT02575079
- Testing
- Parafilm
- Where
- United States
- Volunteers
- 119 people
- Sponsor
- Emory University
Shock, Septic
Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis: A Pilot Feasibility Study
The objective of this pilot study is to assess overall feasibility prior to embarking on a larger randomized pragmatic trial comparing the clinical effectiveness of fluid resuscitation with NS versus LR for pediatric patients…
- Trial name
- PRoMPT BOLUS (NCT03340805)
- Testing
- Lactated Ringer, Normal saline
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Children's Hospital of Philadelphia
CLABSI - Central Line Associated Bloodstream Infection
Sodium Citrate 4% Locking Solution for Children Requiring Home Parenteral Nutrition
This study an open label prospective observational cohort study to evaluate the safety and efficacy of sodium citrate 4% locking solution in preventing central line associated blood stream infection in children requiring long…
- Trial name
- NCT04756427
- Testing
- Sodium Citrate 4% Inj Syringe 3Ml
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Johns Hopkins University
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
Leukemia, Lymphoma
Preemptive Ethanol Lock Therapy in Pediatric Bloodstream Infection
The study team will compare hospital length of stay (LOS) and attributable length of stay (ALOS, the LOS attributable to CRI), in a randomized, un-blinded prospective trial utilizing short-dwell ethanol-lock therapy (ELT) (4…
- Conditions
- Leukemia, Lymphoma, Blood Disorders, Solid Tumors
- Trial name
- NCT02095951
- Testing
- Ethanol lock therapy (ELT)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Children's Hospital of Michigan
Bacteremia, Sepsis
Rapid Blood Culture Identification Panel in Pediatric Patients in Guatemala
The purpose of this study is to assess the clinical impact of a rapid multiplex PCR blood culture identification panel on time to optimal antimicrobial therapy when compared to conventional microbiological culture methods in…
- Trial name
- NCT05314816
- Testing
- Blood culture identification panel
- Where
- Guatemala
- Volunteers
- 479 people
- Sponsor
- University of Colorado, Denver
Bacteremia, Soft Tissue Infections
Safety, Efficacy, and Pharmacokinetics (PK) of Daptomycin (MK-3009) in Japanese Pediatric Subjects With Complicated Skin and Soft Tissue Infections (cSSTI) and Bacteremia (MK-3009-029)
The purpose of this study is to assess the safety, efficacy and pharmacokinetic (PK) parameters of daptomycin for injection in Japanese pediatric participants aged 1 to 17 years with complicated skin and soft tissue infection…
- Conditions
- Bacteremia, Soft Tissue Infections, Skin Diseases, Infectious
- Trial name
- NCT03643952
- Testing
- Daptomycin for Injection
- Where
- 16 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Merck Sharp & Dohme LLC
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
Catheter-Related Infections, Central Venous Catheters
Advanced Dressings for CVC Infection Prevention in PICU
Randomised, single-blind clinical trial comparing chlorhexidine gluconate-impregnated transparent dressings versus conventional transparent dressings in the prevention of central venous catheter-related bloodstream infections…
- Conditions
- Catheter-Related Infections, Central Venous Catheters, Bloodstream Infection, Pediatric Intensive Care Units
- Trial name
- NCT07175116
- Testing
- 3M™ Tegaderm™ Antimicrobial Transparent Dressing (chlorhexidine gluconate-impregnated), Conventional transparent polyurethane dressing
- Where
- Spain
- Volunteers
- 250 people
- Sponsor
- University of Seville
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
Sepsis, Gastroenteritis
Utility of Ultrasound Assessment of the Inferior Vena Cava in Patients With Sepsis and Dehydration
Conduct a randomized, controlled trial looking at how the use of ultrasound analyzing the inferior vena cava impacts the management and outcomes of pediatric emergency department patients undergoing evaluation and treatment of…
- Conditions
- Sepsis, Gastroenteritis, Dehydration
- Trial name
- NCT02568189
- Testing
- SonoSite Maxx Series Ultrasound System
- Where
- United States
- Volunteers
- 112 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Sepsis, Procalcitonin
Impact of a Procalcitonin Testing and Treatment Algorithm on Antibiotic Use and Outcomes in the Pediatric Intensive Care Unit
The timely use of antibiotics can reduce morbidity and mortality associated with bacterial infections, particularly in the intensive care unit setting (ICU).
- Conditions
- Sepsis, Procalcitonin, Antimicrobial Stewardship
- Trial name
- ProPICU (NCT03440918)
- Testing
- Procalcitonin-Guided Antimicrobial Stewardship, Baseline Antimicrobial Stewardship
- Where
- United States
- Volunteers
- 271 people
- Sponsor
- Vanderbilt University Medical Center
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
Fever, Sepsis
AION BIOSYSTEMS, INC. Tempshield for Continuous Tempreature Monitoring
The purpose of this research study is to evaluate the effectiveness of the AION BIOSYTEMS, INC. tempshield ("Shield") temperature monitoring device and platform in detecting body temperature for children 2-4 years old.
- Trial name
- NCT07145541
- Testing
- Aion Tempshield Device
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- AION Biosystems
Sepsis, Systemic Inflammatory Response Syndrome
PPV to Guide Fluid Management in the PICU
Children who are critically ill often require large amounts of fluid during their acute illness. It has been shown in multiple studies that appropriate administration of fluid decreases morbidity and mortality, but giving too…
- Trial name
- PPV (NCT02308371)
- Testing
- Automated Pulse Pressure Variation
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of North Carolina, Chapel Hill
Pediatric Sepsis-induced MODS
GM-CSF for Reversal of immunopAralysis in pediatriC sEpsis-induced MODS Study
This study is an open-label, multi-center, interventional trial in which children with sepsis-induced MODS undergo surveillance immune function testing beginning on Day 2 of MODS.
- Trial name
- GRACE (NCT03769844)
- Testing
- GM-CSF
- Where
- 8 sites in United States
- Volunteers
- 75 people
- Sponsor
- Nationwide Children's Hospital
Acute Myeloid Leukemia, Neutropenia
Home Away From Home - Medical Outcomes
Treatment for pediatric acute myeloid leukemia (AML) involves intensive chemotherapy regimens that result in periods of profound neutropenia leaving patients susceptible to severe infectious complications.
- Conditions
- Acute Myeloid Leukemia, Neutropenia, Bacteremia
- Trial name
- Aim 1 (NCT02774850)
- Where
- 17 sites in United States
- Volunteers
- 610 people
- Sponsor
- Children's Hospital of Philadelphia