Active clinical trials for "Sepsis"

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. The investigators will conduct a multi-site cohort study with 7,000 dyads in Uganda and engage with local stakeholders (e.g., patients, healthcare workers, and health policy-makers) to develop an evidence-based bundle of interventions that address key practice gaps and the critical factors leading to death and complications in these dyads. In the investigator's epidemiological study of post-delivery post-discharge outcomes in 3,236 dyads in Uganda (2017-2020), results indicated that most newborn and maternal readmissions were due to infectious illness (i.e. sepsis, surgical site infections, malaria), and primarily occurred early in the post-discharge period. Thus, the focus of this study will be identifying interventions that target these common and early outcomes, for both mothers and newborns, using WHO recommendations, patient and caregiver experiences, and stakeholder recommendations. If successful, results will inform the next steps of this project, which is the external validation of the model and clinical evaluation of a personalized approach to improving health outcomes and health-seeking behaviour for mothers and newborns.

This is a randomized double-blind controlled study with the primary aim of scientifically evaluating the potential effects of paracetamol and ibuprofen in the management of sepsis by comparing their fever-reducing efficacy in septic patients. Sepsis is recognized as a severe form of systemic inflammatory response syndrome (SIRS) characterized by organ dysfunction resulting from severe infections. This study aims to address a significant aspect of fever management in septic patients by objectively assessing the fever-reducing potential of paracetamol and ibuprofen.

This is a prospective, multinational, multicentre, randomised, parallel-group, open-label study to assess the safety, tolerability and performance of the NucleoCapture extracorporeal apheresis device in the reduction of circulating cell-free DNA (cfDNA)/Neutrophil Extracellular Traps (NETs) in sepsis patients.

Neonatal sepsis still considered as one of the major causes of mortality and morbidity during the neonatal period due to high vulnerability of that age group. The blood culture is considered as the gold standard for diagnosis of bacterial sepsis, however in early onset neonatal sepsis (EONS) the inability to isolate a microbial pathogen does not exclude sepsis. The reason behind the high number of culture-negative cases is not clear and might be attributed to low levels of bacteremia or small volumes of blood obtained from sick infants. Also maternal antibiotic treatment before or during delivery may theoretically mask detection of bacteremia in the newborn. In addition these cultures have a 48-72 hours delay to obtain results. Therefore, the combination of clinical assessment and laboratory biomarkers currently are the bases for diagnosis of neonatal sepsis. Recently interleukin-27 (IL-27) has been looked at as another candidate biomarker in the serum for diagnosis of sepsis in both adult and children. Interleukin-27 (IL-27), a novel member of the IL-12 family, was first discovered in 2002. IL- 27 is primarily synthesized by antigen-presenting cells, and it is widely expressed in a myriad of cells, including placental trophoblast cells. Although multiple studies have reported IL-27 as an essential regulator of immune response and inflammation, its precise role in the immune response is still disputable. Conventionally, IL-27 has been envisaged as a potent promoter of inflammation. When first discovered, it was characterized as a promoting factor in the rapid initiation of inflammatory responses, processing the ability to stimulate the rapid expansion of naïve CD4+T and then the production of IFN-?, which has been demonstrated by various subsequent studies. The aim of this study was to evaluate the usage of elevated IL-27 in cord blood as an early predictor biomarker for EONS.

Although new techniques like extracorporeal blood purification have lately emerged, septic patients still have very high hospital mortality rates. Sepsis can be induced by either viremia, bacteriemia or in some cases both. Many studies have reported the effectiveness of different hemadsorbers, but patient sample sizes have been inadequate for definitive conclusions. Secondly, there are still no clear inclusion criteria as well as criteria for when to cease hemadsorption mostly due to immune dysregulation or cascade coagulation disorders. The aim of this observational prospective registry is to evaluate the effectiveness of the Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) in the treatment of septic ICU patients and to evaluate which cluster of these patients should benefit most with this therapy.

The overall objective of this proposed research is the derivation of a biomarker-enhanced artificial intelligence (AI)-based pediatric sepsis screening tool (PSCT) (software) that can be used in combination with the hospital's electronic health record (EHR) system to monitor and assess real-time emergency department (ED) electronic health record (EHR) data towards the enhancement of early pediatric sepsis recognition and the initiation of timely, aggressive personalized sepsis therapy known to improve patient outcomes. It is hypothesized that the screening performance (e.g., positive predictive value) of the envisioned screening tool will be significantly enhanced by the inclusion of a biomarker panel test results (PERSEVERE) that have been shown to be effective in prediction of clinical deterioration in non-critically ill immunocompromised pediatric patients evaluated for infection. It is also hypothesized that enhanced phenotypes can be derived by clustering PERSEVERE biomarkers combined with routinely collected EHR data towards improved personalized medicine.

Central line-associated bloodstream infections (CLABSIs) are the most common healthcare-associated infection in children and are associated with morbidity and mortality. This study will attempt to identify the source of bloodstream infections (BSIs) in children with CLABSI because we hypothesize that many of the BSIs that are currently classified as CLABSIs are actually laboratory-confirmed bloodstream infections (LCBI) that may be a result of mucosal barrier injury (MBI), also known as MBI-LCBI. In order to study this, we will isolate bacteria from multiple body sites of children that have BSI in order to compare these bacteria to the strain growing in their blood using whole-genome DNA sequencing. We will also evaluate biomarkers of MBI of the respiratory tract and GI tract.

The goal of this clinical trial is to propose a seamless intervention linking rapid bacterial isolate identification and antibiotic resistance gene detection and targeted antibiotic prescription to minimise time between infection onset and appropriate treatment in patients with Pseudomonas aeruginosa or carbapenemase producing Enterobacterales infections. This is an investigator initiated trial. The primary hypothesis is that these interventions will lead to improved clinical outcomes amongst patients with hospital-acquired bloodstream infection, hospital-acquired pneumonia or ventilator-associated pneumonia due to carbapenem non-susceptible Pseudomonas aeruginosa or Enterobacterales, compared to standard antibiotic susceptibility testing. Patients will be randomised to either a control or intervention arm. Patients randomised to the intervention arm will have relevant specimens analysed by rapid microbiological diagnostics and will have early availability of ceftazidime-avibactam if appropriate. Patients randomised to the control arm, will have samples analysed by clinical microbiology laboratories using standard of care diagnostics. Antibiotics will be available to these patients as per usual institutional practice.

There is a variety of in vitro, in vivo (animal model), and human case series data which suggests that the addition of ertapenem to cefazolin could improve outcomes in methicillin-susceptible S. aureus bacteremia. No randomized controlled trial has been performed.

Sepsis is a life-threatening complication of infection that can be difficult to recognize and treat promptly. Timely administration of antibiotics for emergency department (ED) patients with sepsis is challenging. The goal of this study is to determine the potential effectiveness and unintended consequences of reorganizing ED care for patients with suspected sepsis.