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NCT ID: NCT06108791 Not yet recruiting - Clinical trials for Surgical Site Infection

Intraoperative Oxygen Concentration on Incidence of Surgical Site Infection

Start date: January 2024
Phase: N/A
Study type: Interventional

Surgical site infections (SSI) are the most common healthcare-associated infections and sources of morbidity and over-mortality. Factors that have been proven to reduce SSI include antimicrobial prophylaxis, maintenance of perioperative normothermia, avoidance of hyperglycemia, proper surgical techniques, and adequate pain relief postoperatively

NCT ID: NCT06107569 Not yet recruiting - Clinical trials for Clostridium Difficile Infections

Treatment of CDI and Recurrence With Fecal Microbiota Transplant Using Promicrobioma

Start date: May 1, 2024
Phase: Phase 3
Study type: Interventional

The increasing inappropriate use of antimicrobials, in addition to increasing selective pressure and inducing environmental resistance, is also a risk factor for the development of Clostridioides difficile infection (CDI). The intestinal microbiota is mainly composed of the phyla Firmicutes, Bacteroidetes, Acinobacteria, Proteobacteria, Fusobacteria and Verrucomicrobia, and more than 90% of the phylum Firmicutes is composed of Clostridium spp. (two). The inappropriate use of antimicrobials initiates a process of dysregulation of the microbiome, called dysbiosis, and it is from the selection of genera and species of bacteria that will dominate the intestine that pseudomembranous colitis can set in with an increased burden of Clostridioides difficile, a gram positive, anaerobic, spore-forming, that produces two enterotoxins, toxin A and toxin.

NCT ID: NCT06103500 Not yet recruiting - Sepsis Clinical Trials

Integrated Clinical Decision Support for Empiric Antibiotic Selection in Sepsis

IDEAS-CRXO
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

As antibiotic resistance increases globally, it becomes more difficult to select empiric antibiotic therapy, particularly in patients with sepsis who stand to benefit from early adequate treatment. In particular it is difficult for clinicians to balance antibiotic stewardship principles (the need to avoid unnecessary prescribing of antibiotics that have an excessively broad spectrum of activity that favour resistance development) and under treatment. The integration of multiple risk variables for resistance are hard for clinicians to translate into clinical action, and is seemingly at odds with the natural inclination to provide heuristic/emotion-based antibiotic selection. The inappropriate treatment of sepsis is not uniformly too broad, or too narrow, and there is a need to optimize and tailor selection of antibiotic therapy to each patient, such that those that are at risk for resistant organisms receive broad therapy, and those that are not at risk, receive narrower antibiotic agents. Clinicians need support picking the right antibiotic for each patient, and from this they can potentially drive reduction of unnecessarily broad antibiotic prescribing while preserving adequacy of treatment. Individualized clinical prediction models and decision support interventions are promising approaches that meet these needs by improving the classification of patient risk for antibiotic resistant or susceptible infections in sepsis. Unfortunately, few have been validated in the clinical setting and larger rigorous studies are needed to provide the evidence to support broader clinical adoption. The investigators will perform a cluster randomized cross-over trial of an individualized antibiotic prescribing decision support intervention for providers treating hospitalized patients with suspected sepsis. The aim of this trial is to determine whether a stewardship led clinical decision support intervention can improve antibiotic de-escalation in patients with sepsis while maintaining or improving adequacy of antibiotic coverage. This decision support intervention will be based on a combination of proven decision heuristics (for Gram-positive organisms) and modelled predicted susceptibilities (for Gram-negative organisms) that are individualized to the patient. The primary outcome will be the proportion of patients de-escalated from their initial empiric regimen within 48 hours.

NCT ID: NCT06102070 Not yet recruiting - Infectious Disease Clinical Trials

Genetic Susceptibility to Severe Infections

PREDISPOSITI
Start date: November 2, 2023
Phase:
Study type: Observational

Only a fraction of individuals infected with microbes develop clinical disease. This observation raises fundamental questions about the pathogenesis of infectious diseases. There is a complex interaction between environmental (microbial and non-microbial) and human (genetic and non-genetic) factors. This will determine the quality of the immune response against the infectious agent and the clinical manifestation. By definition, individuals who die from an infection have defective immunity to the pathogen in question (immune agent (immune deficiency). The investigation of individual variability in the development of infectious diseases began in the early 20th. The first evidence to support the hypothesis that individual variability variability and immune deficiencies were hereditary came from observations of familial cases or genetic isolates genetic isolates (from a homogeneous population) of rare or common infectious diseases, which in some cases Mendelian heredity hat predisposition to infectious diseases runs in families even more so than diseases associated with less determined environmental factors, such as certain cancers. such as certain cancers. Finally, studies comparing the rate of concordance of infectious diseases between monozygotic and dizygotic twins also implicate genetic factors in disease susceptibility. These observations were validated by the discovery of genetic defects associated with severe infectious diseases, leading to proof of concept. While a number of hereditary immune deficiencies associated with susceptibility to multiple pathogens or microorganisms, a growing number of new and rare new and rare immune deficiencies conferring restricted susceptibility to infections caused by a single caused by a single pathogen family, or even a single pathogen, in otherwise healthy children, have recently been identified (one gene, one pathogen). As a result, a dozen Mendelian clinical syndromes characterized by restricted susceptibility are now known. Over the last 20 years, it has been proven that these "idiopathic" infections were immune deficiencies. The investigators now wish to study new severe infections, including but not limited to viral, fungal and bacterial infections. viral, fungal, bacterial and parasitic infections. This should lead to a better understanding of the pathophysiology of each disease, the development of new therapeutics and better patient care.

NCT ID: NCT06102044 Not yet recruiting - Neonatal Infection Clinical Trials

Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania

Start date: June 30, 2024
Phase: Phase 3
Study type: Interventional

Bacterial infections among young infants, including sepsis, meningitis, and pneumonia, continue to cause a substantial number of deaths globally. Zinc supplementation in combination with standard antibiotic therapy may represent a new intervention to reduce mortality and improve treatment outcomes for young infants with clinical severe infection. The Investigators will conduct a randomized, double-blind, placebo-controlled trial of zinc supplementation among young infants 0-59 days with severe clinical infection. The trial will enroll 3,250 Tanzanian infants hospitalized with clinical severe infection as defined by WHO Integrated Management of Childhood Illness (IMCI) guidelines. Enrolled infants will receive standard clinical management including antibiotics and will be randomized to receive either a 14-day course of twice-daily 5 mg elemental zinc (10 mg per day) or a matching placebo regimen.

NCT ID: NCT06093035 Not yet recruiting - Clinical trials for Microbial Colonization

Analysis of Urinary, Vaginal and Intestinal Microbiota in Patients With Neurogenic Bladder

Start date: November 10, 2023
Phase:
Study type: Observational [Patient Registry]

The neurogenic bladder and bowel are two pathological conditions occurring when damaged innervation results in functional alteration of both the bladder and the bowel with a clinical presentation that can vary from retention to incontinence often associated with an increased risk of infection. Specific microbiological patterns of urinary microbiota are associated with states of well-being of the host and play protective and preventive functions for numerous urological pathologies such as urinary tract infections, urinary incontinence and bladder tumors. What the "healthy" profile of the bladder microbiota is in subjects with neurogenic bladder appears currently poorly reported in literature data. Indeed, in these populations different strains of uropathogenic microorganisms, such as E.Coli, Klebsiella, Pseudomonas and Enterococcus, are dominant compared to healthy subjects where Lactobacillus predominates. The characterization of the gut microbiota in terms of composition can be a key tool for understanding the effects that preventive therapeutic and nutritional approaches or clinical procedures have on it, subsequently offering the possibility of improving and complementing these treatments. Among human microbiota, the vaginal one, the "vaginoma", is among the most studied for its correlation with female health status. The "core" of the vaginal microbiome is Lactobacillus which under physiological conditions is represented in particular by Lactobacillus Crispatus, Lactobacillus Iners, Lactobacillus Jensenii and Lactobacillus Gasseri. Immune cells and related PRRs receptors interact with the microorganisms in the vaginal environment of the vaginal environment are the immune cells and the related PRRs receptors thus the close relationship between microbiome and immunity as well as between vaginoma and genitourinary well-being is now evident. The characterization of the gut, urinary and vaginal microbiota in patients with neurogenic bladder secondary to spina bifida and multiple sclerosis can help identify a "health promoting" profile to personalize and characterize the therapeutic approach.

NCT ID: NCT06089174 Not yet recruiting - Infections Clinical Trials

Assessment of the Increased Risk of Infection Following an Ultratrail

INFultra
Start date: October 2023
Phase: N/A
Study type: Interventional

The increase in the practice of running has encouraged a proliferation of studies evaluating the impact of this sport on health. A number of these studies have looked at the influence of endurance events on the immune system. After prolonged exercise, a systemic inflammatory syndrome sets in, with repercussions for the functioning of the immune system. The number of lymphocytes in the blood is reduced, the function of natural killer (NK) cells is impaired and secretory immunity is impaired. During this period of immunosuppression, often referred to as the 'open window', the host may be more susceptible to micro-organisms that bypass the first line of defence. The invetigators' hypothesis is therefore that ultratrailers are overexposed to the risk of infection due to immunodepression resulting from practising this sport. In order to support this hypothesis, the investigators would like to look at infectious complications in general and ear-nose and throat episodes (rhinitis, pharyngitis, laryngitis, etc.) in particular, which are the most common infections encountered in primary care, along with urinary tract infections.

NCT ID: NCT06083623 Not yet recruiting - Clinical trials for Respiratory Syncytial Virus Infections

A Trial to Evaluate the Efficacy and Safety of TNM001 for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants

Start date: October 6, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), neutralizing antibody and antidrug antibody (ADA) response for TNM001 in infants entering their first RSV season.

NCT ID: NCT06075927 Not yet recruiting - Clinical trials for Stem Cell Transplant

Multivirus-specific T Cells in the Treatment of Refractory CMV and/or EBV Infection After Allo-HSCT

Start date: November 1, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

To evaluate the safety and tolerability of partial HLA-matched VSTs against both CMV and EBV viruses in recipients of allogeneic hematopoietic stem cells with refractory viral infections (CMV and/or EBV). Preliminary evaluation of the efficacy of partial HLA-matched VSTs against both CMV and EBV viruses in recipients of allogeneic hematopoietic stem cells with refractory viral infections (CMV and/or EBV); To monitor the duration and expansion of multi-virus VSTs cells after infusion.

NCT ID: NCT06073834 Not yet recruiting - Clinical trials for VAP - Ventilator Associated Pneumonia

LUNG INFECTION IN ICU (LUNG-I3)

LUNG-I3
Start date: November 2023
Phase:
Study type: Observational

objective of LUNG-I3 study is to assess the quantitative and functional differences in cells between blood and bronchoalveolar lavage (BAL) fluid after an infection, with a special focus on alveolar macrophages and neutrophils