Clinical trials: Systemic Inflammation
Sepsis
Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates
This is a phase I open label multi-dose study to investigate the pharmacokinetics and safety of piperacillin-tazobactam in infants < 61 days of age with suspected sepsis. There will be four cohorts of 8 infants each: 1.
- Trial name
- NCT00873327
- Testing
- piperacillin-tazobactam
- Where
- 4 sites in United States
- Volunteers
- 32 people
- Sponsor
- Phillip Brian Smith
Sepsis, Critical Illness
Optimizing Vancomycin Therapy in Children
The purpose of Opt Vanc is to evaluate the feasibility of Bayesian dose adaptation, based on a previously-developed population pharmacokinetic (PK) model and a single optimally timed PK sample, to predict vancomycin area under…
- Conditions
- Sepsis, Critical Illness, Infections, Drug Toxicity
- Trial name
- Opt Vanc (NCT05691309)
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Children's Hospital of Philadelphia
Sepsis
The CRISIS Prevention Study
Despite strict hand washing, sterile technique, and antibiotic-coated catheters, nosocomial infection and sepsis remain the leading acquired causes of morbidity and mortality in critically ill children.
- Trial name
- CRISIS (NCT00395161)
- Testing
- Metoclopramide, Zinc, Glutamine
- Where
- 7 sites in United States
- Volunteers
- 293 people
- Sponsor
- Michael Dean
Bacteremia
Hub Cleansing to Prevent Hub Infection
Central venous catheter infections are common preventable adverse events among hospital patients. Microbes may enter catheter hubs, also known as needleless connectors, and result in downstream contamination.
- Trial name
- HUC-PHIN (NCT01563406)
- Testing
- 15 second scrub, 5 second scrub, 3.15% chlorhexidine/70% isopropyl alcohol
- Where
- United States
- Volunteers
- 149 people
- Sponsor
- Rush University Medical Center
Maternal Sepsis, Neonatal Sepsis
Smart Discharges for Mom & Baby
This study aims to build a predictive algorithm that identifies mother-newborn dyads most at risk of death or complications in the 6 weeks after birth.
- Trial name
- NCT05730387
- Testing
- Observational only
- Where
- Canada
- Volunteers
- 7,182 people
- Sponsor
- University of British Columbia
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
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
Congenital Heart Disease in Children, Inflammatory Response
STeroids to REduce Systemic Inflammation After Infant Heart Surgery
This study's objective is to determine the pharmacokinetics (PK)/pharmacodynamics (PD), safety and efficacy of methylprednisolone in infants undergoing heart surgery with cardiopulmonary bypass.
- Trial name
- STRESS (NCT03229538)
- Testing
- Methylprednisolone, Isotonic saline
- Where
- 23 sites in United States
- Volunteers
- 1,263 people
- Sponsor
- Kevin Hill
Sepsis
Sepsis-Associated Purpura Fulminans International Registry - Europe
Sepsis-associated Purpura fulminans (SAPF) is a rare life-threatening condition. It is characterized by multiple skin lesions which rapidly progress to necrosis and gangrene.
- Trial name
- SAPFIRE (NCT02238795)
- Where
- 3 sites in Germany
- Volunteers
- 28 people
- Sponsor
- Jena University Hospital
Neonatal Sepsis, Low Birth Weight
Safety of Skin Cleansing With Chlorhexidine in Preterm Low Birth Weight Infants
The purpose of this study is to examine if single skin cleansing with 0.25% chlorhexidine affects skin condition, temperature, and bacterial colonization in stable preterm (28-36 weeks gestational age) low birth weight (1001-2000…
- Trial name
- NCT00947518
- Testing
- Chlorhexidine, Normal saline
- Volunteers
- 60 people
- Sponsor
- All India Institute of Medical Sciences
Sepsis
Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis
Neonatal bacterial sepsis is a major cause of mortality and morbidity and early antibiotic therapy is crucial for treatment success.
- Trial name
- NCT00926497
- Testing
- Procalcitonin-guided decision making
- Where
- Switzerland
- Volunteers
- 121 people
- Sponsor
- Luzerner Kantonsspital
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
HIV Infections, Viremia
Enhanced Virologic Monitoring for Pregnant and Postpartum Women With HIV
The goal of this study is to learn about supporting pregnant and postpartum women living with HIV with treatment adherence. The investigators will conduct a pilot study of an intervention that includes peer counseling about viral…
- Conditions
- HIV Infections, Viremia, Pregnancy Related
- Trial name
- NCT05845619
- Testing
- Enhanced virologic monitoring
- Where
- 4 sites in Kenya
- Volunteers
- 550 people
- Sponsor
- University of California, San Francisco
Sepsis
Algorithm for Predicting the Unfavorable Course of Sepsis in Children
A comprehensive strategy will be used to investigate the relationship and correlation between 4 diagnostically significant markers relevant for early diagnosis and prediction of complications and death in the development of…
- Trial name
- NCT05908162
- Testing
- Bood leukocyte subsets
- Where
- Belarus
- Volunteers
- 185 people, healthy volunteers welcome
- Sponsor
- The Republican Research and Practical Center for Epidemiology and Microbiology
Malaria, Seizures
Aggressive Antipyretics for Fever Reduction in CNS Malaria
The study will examine whether prophylactic and scheduled treatment with acetaminophen and ibuprofen can decrease the maximum temperature experienced during the acute illness in children with CNS malaria.
- Conditions
- Malaria, Seizures, Coma, Parasitemia
- Trial name
- NCT03399318
- Testing
- Acetaminophen, Ibuprofen
- Where
- 3 sites in Malawi, Zambia
- Volunteers
- 256 people
- Sponsor
- University of Rochester
Serious Systemic Infections, Necrotizing Enterocolitis
Metronidazole Pharmacokinetics (PK) in Premature Infants
Yearly in the United States over 500,000 newborns are delivered prematurely. This population is at high risk of catastrophic bowel disease known as necrotizing enterocolitis.
- Trial name
- PTN_METRO (NCT01222585)
- Testing
- Metronidazole
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Michael Cohen-Wolkowiez
Premature Birth, Sepsis
Characteristics of Cord Blood Immunologic Parameters of Infants <32 Weeks Gestation
Infants in the NICU are at high risk for morbidity and mortality from infections of any onset. Diagnosis of these infections is imperfect at best.
- Trial name
- AOS (NCT00524394)
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- The University of Texas Health Science Center, Houston
Bloodstream Infection
Ethanol Locks for the Treatment of Central Venous Line Infections
Ethanol Locks as an Adjunct Treatment for Central Venous Line Infections Purpose To evaluate the effectiveness of a 70% ethanol lock solution when used as an adjunct therapy with antibiotics to treat central venous line…
- Trial name
- NCT00680459
- Testing
- 70% ethanol, heparin flush solution
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Baystate Medical Center
Preterm Infant, Early-Onset Neonatal Sepsis
Utility of Placental/Umbilical Cord Blood in Early Onset Neonatal Sepsis in Very Low Birth Weight Infants
This study evaluates the utility of placental/umbilical cord blood (PUCB) to perform the baseline workup testing for EONS in Very Low Birth Weight Infants: CBC (Complete Blood Count) with differential, Immature/Total ratio (I/T…
- Conditions
- Preterm Infant, Early-Onset Neonatal Sepsis, Umbilical Cord
- Trial name
- NCT03694613
- Testing
- Placental/Umbilical Cord Blood sample
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- The University of Texas Medical Branch, Galveston
Cytokine Storm (Covid-19)
Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm
This was a randomized, double-blind, placebo-controlled, 29-day, multicenter study to assess the efficacy and safety of ruxolitinib + standard-of-care (SoC) therapy, compared with placebo + SoC therapy, in patients aged ≥12 years…
- Trial name
- RUXCOVID (NCT04362137)
- Testing
- Ruxolitinib
- Where
- 61 sites in United States, Argentina and 10 more
- Volunteers
- 432 people
- Sponsor
- Novartis Pharmaceuticals