Clinical trials: Systemic Inflammation
Late-Onset Neonatal Sepsis
Evaluation of bioMarkErs to Reduce Antibiotics Use in hospitalizeD nEonates
Late-onset neonatal sepsis (LOS), occurring in newborn of at least 7 days of life, is frequently observed in Neonatal Intensive Care Units (NICUs) and potentially severe (mortality, neurologic and respiratory impairments).
- Trial name
- EMERAUDE (NCT03299751)
- Testing
- Diagnostic performances of biomarkers combination
- Where
- 2 sites in France
- Volunteers
- 233 people
- Sponsor
- Hospices Civils de Lyon
Systemic Inflammatory Response Syndrome
Effect of Menstrual Cycle on Traumatic Systemic Response
It is aimed to evaluate pathophysiology of systemic responses to trauma via using interleukin (IL) -1 and IL-6 levels and determining timing of surgery through phases of menstrual cycle.
- Trial name
- NCT03283345
- Testing
- modified radical mastectomy
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Kocaeli University
Respiratory Insufficiency, Metabolic Disease
Is Venous to Arterial Conversion (v-TAC) of Blood Gas Reliable in Critical Ill Patients in the ICU?
Objective: Arterial blood gas (ABG) is essential in the clinical assessment of potential acutely ill patients venous to arterial conversion (v-TAC), a mathematical method, has recently been developed to convert peripheral venous…
- Conditions
- Respiratory Insufficiency, Metabolic Disease, Acidosis, Alkalosis
- Trial name
- NCT03309423
- Testing
- venous to arterial conversion (v-TAC)
- Where
- Denmark
- Volunteers
- 50 people
- Sponsor
- Aalborg University
Neonatal Sepsis
Use of Probiotics to Reduce Infections, Death and ESBL Colonisation
This study examines the effect of oral probiotic treatment to newborns on preventing hospitalizations, death and colonization with Extended-spectrum beta-lactamase-producing Gram negative bacteria.
- Trial name
- ProRIDE (NCT04172012)
- Testing
- Labinic (R) probiotic mixture
- Where
- Tanzania
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Haydom Lutheran Hospital
Candidiasis
Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis
The study will evaluate how effective and how safe the drug micafungin is when compared to the drug amphotericin B deoxycholate in treating neonates and young infants with certain fungal infections.
- Trial name
- MAGIC-2 (NCT00815516)
- Testing
- micafungin, amphotericin B deoxycholate
- Where
- 17 sites in United States, Brazil and 10 more
- Volunteers
- 30 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Infant, Newborn, Infant, Low Birth Weight
Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants
This large multicenter double-masked clinical trial tested whether supplementation of standard neonatal parenteral nutrition with glutamine would reduce the risk of death or late-onset sepsis in extremely-low-birth-weight (ELBW…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Glutamine (NCT00005775)
- Testing
- Glutamine
- Where
- 15 sites in United States
- Volunteers
- 1,433 people
- Sponsor
- NICHD Neonatal Research Network
Perinatal Listeriosis
Neurological Consequences of Perinatal Listeriosis Infection
The purpose of the study is to determine whether perinatal listeriosis is associated with long-term neurological consequences, and to evaluate the respective contribution of perinatal sepsis, of prematurity and of the known…
- Trial name
- MONALISABABY (NCT02580812)
- Testing
- Clinical and neuropsychological evaluation procedure
- Where
- France
- Volunteers
- 53 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Sepsis
Pro-adrenomedullin as a Prognostic Marker in Neonatal Sepsis
The aim of this study was to clarify the prognostic value of serum pro-Adrenomedullin level in neonatal sepsis. Eighty term and preterm neonates with sepsis were enrolled in this study.
- Trial name
- NCT01362504
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Acinetobacter Bacteraemia
A Prospective Observational Study of Patients With Drug Resistant Acinetobacter Baumannii Bacteremia
Extensively and multi-drug resistant A. baumannii (AB) represent an emerging threat in hospitals locally and worldwide. There is lack of prospective comparative clinical data to guide optimal strategy for treating such…
- Trial name
- ANTI-AB (NCT01511224)
- Where
- 3 sites in Taiwan
- Volunteers
- 200 people
- Sponsor
- National Taiwan University Hospital
Procalcitonin, Fever Without Source
Impact of Procalcitonin on the Management of Children Aged 1 to 36 Month Presenting With a Fever Without a Source
Serious bacterial infections are often difficult to detect in children with fever without source. Procalcitonin is a better blood marker of infection than White blood cell count and possibly than C-reactive protein.
- Conditions
- Procalcitonin, Fever Without Source, Bacterial Infection, Bacteremia
- Trial name
- NCT00692848
- Testing
- Procalcitonin dosage PCT-Q test (Brahms, Germany)
- Where
- Canada
- Volunteers
- 384 people
- Sponsor
- St. Justine's Hospital
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
Neonatal SEPSIS
Intravenous and Oral Fosfomycin in Hospitalised Neonates With Clinical Sepsis
Neonatal sepsis has a high risk of morbidity and mortality. The current WHO and national guidelines recommend antibiotics to which resistance is reported in neonatal populations, although the available data is limited.
- Trial name
- NeoFosfo (NCT03453177)
- Testing
- Standard of Care + Fosfomycin, PK, Analysis of Bacterial Isolates
- Where
- Kenya
- Volunteers
- 120 people
- Sponsor
- Drugs for Neglected Diseases
Sepsis
Establishment of Early Diagnosis and Monitoring Model for Sepsis Patients
In recent years, although the clinical treatment of sepsis has been greatly improved, it is still an important cause of death in ICU patients, and seriously threatens human health.
- Trial name
- EDAMMFS (NCT04974411)
- Testing
- infection, sepsis
- Where
- China
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
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
Cardiac Surgery, Extracorporeal Circulation; Complications
Evaluation of Blood and Cardiac Protein O-GlcNAcylation Levels in Cardiac Surgery in Children
Cardiac surgery requires the use of extracorporeal circulation (ECC). Age-related differences in inflammatory response, the greater susceptibility of immature organ systems to injury and the larger ratio of extracorporeal…
- Conditions
- Cardiac Surgery, Extracorporeal Circulation; Complications, Metabolism, Low Cardiac Output
- Trial name
- CardiOGlcNAc (NCT06754709)
- Where
- France
- Volunteers
- 300 people
- Sponsor
- Nantes University Hospital
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
Bloodstream Infection, Salmonella Bacteremia
Clinical Decision Support in Non-typhoidal Salmonella Bloodstream Infections in Children
In sub-Saharan Africa, non-typhoidal Salmonella (NTS) are a frequent cause of bloodstream infection, display high levels of antibiotic resistance and have a high case fatality rate (15%).
- Conditions
- Bloodstream Infection, Salmonella Bacteremia, Malaria,Falciparum, Severe Malaria
- Trial name
- DeNTS (NCT04473768)
- Where
- Belgium
- Volunteers
- 1,880 people
- Sponsor
- Institute of Tropical Medicine, Belgium
Neonatal SEPSIS, Enterocolitis, Necrotizing
CD64 Measurement in Neonatal Infection and Necrotising Enterocolitis
Bacterial infections are a major cause of death in newborn infants. And are linked to complications including: sepsis (an over exaggerated immune response to infection) and necrotising enterocolitis (a potentially fatal…
- Trial name
- NCT01005589
- Where
- United Kingdom
- Volunteers
- 59 people
- Sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
Vitamin A Deficiency, Pediatric
Efficacy and Safety of Vitamin A Treatment for Children With Sepsis
The prevalence of vitamin A deficiency was found high in children with sepsis. Whether those patients will benefit from the vitamin A supplementation is unknown.
- Conditions
- Vitamin A Deficiency, Pediatric, Sepsis
- Trial name
- NCT04127968
- Testing
- Vitamin A, Oil
- Volunteers
- 450 people
- Sponsor
- West China Hospital
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