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Bloodstream Infection clinical trials

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NCT ID: NCT04250168 Terminated - Ebola Virus Disease Clinical Trials

Piloting Clinical Bacteriology in the Ebola Virus Disease Care Response

Bact_EVD
Start date: November 11, 2019
Phase:
Study type: Observational

Despite access to experimental Ebola Virus Disease (EVD)-specific treatments, about 30% of patients still die in the Ebola Treatment Centers (ETC) in DRC. There is limited study done about the potential contribution of bacterial co-infections (in particular bloodstream infections) to this adverse outcome, as blood cultures were so far rarely available in epidemic areas. Findings from patients treated in Europe and the USA, and case discussions in the field call for further investigation. Building further on an ongoing microbiological surveillance project of ITM and INRB in DRC, we are able to set up a research project which will pilot in a standardized manner clinical bacteriology tools (bacterial blood cultures, biomarkers as CRP, procalcitonin and white blood cell differential count, and clinical early warning scores) to study bacterial bloodstream infection in EVD patients in the N-Kivu/Ituri outbreak. This project will add evidence on 1) frequency, causative pathogen and antibiotic resistance profiles of bacterial bloodstream infections, as well as 2) the predictive value of biomarkers and early warning scores, in EVD patients at different timepoints during hospitalization in an ETC in DRC. The results will inform appropriate antibiotic treatment in an EVD setting and improve patient outcomes.

NCT ID: NCT04229511 Not yet recruiting - Clinical trials for Urinary Tract Infections

Development of Risk Score Model and Decision Tree Algorithm for Predicting Infections With CRKp in Colonized Patients

DETERMINE
Start date: April 2020
Phase:
Study type: Observational

DETERMINE trial is a prospective multicenter multinational cohort study. This study will be carried out to predict the risk of bloodstream infections (BSIs) or other types of invasive infection with carbapenem resistant K.pneumoniae in patients being colonized by CRKp. The results of DETERMINE trial would be quite important to prevent unnecessary coverage of carbapenem resistant Klebsiella pneumoniae in empirical treatment of colonized patients. In this study, both risk score model and decision tree algorithm will be constructed and compared with each other in terms of sensitivity, specificity, positive predictive value and negative predictive value.

NCT ID: NCT04229498 Not yet recruiting - Clinical trials for Bloodstream Infection

Comparison of Bloodstream Infections With Carbapenem Hetero-resistant vs Carbapenem Resistant Klebsiella Pneumoniae

COMBAT
Start date: April 2020
Phase:
Study type: Observational

COMBAT trial was contemplated to elucidate unknown clinical relevance of carbapenem heteroresistance among Klebsiella pneumoniae species. Bloodstream infections, type of frequently seen invasive infections that pathogen isolation, identification of antimicrobial resistance mechanisms can be performed efficiently, with carbapenem resistant Klebsiella pneumoniae (CRKp) and carbapenem hetero-resistant Klebsiella pneumoniae will be compared in terms of relevant clinical outcomes such as 30-day mortality rate, 14-day clinical cure rate, 7-day microbiological eradication rate and 90-day relapse/re-infection rate. In addition, underlying molecular resistance mechanisms causing carbapenem hetero-resistance among Klebsiella pneumoniae isolates will be investigated by using whole genome sequences.

NCT ID: NCT04070820 Recruiting - Clinical trials for Bloodstream Infection

Combination Treatment for Enterococcus Faecalis Bacteriemia Multicenter, Observational Study"

Start date: September 1, 2019
Phase:
Study type: Observational

Prospective, multicenter, observational study on the evaluation of efficacy of appropriate monotherapy vs combination treatment for non-complicated Enterococcus faecalis bloodstream infection (EF-BSI). The aims of our study are: Primary: To compare the efficacy of appropriate monotherapy vs combination treatment for EF-BSI, according to standard of care. Secondary: 1. To compare the impact on clinical outcome of the initial combination therapy in the subgroup of patients with enterococcal endocarditis. In this case we will evaluate only the antibiotic treatment administered before the diagnosis of endocarditis assuming that any case of endocarditis will be treated with a combination therapy. 2. To compare the efficacy of combination treatment (vs monotherapy) in the following subgroup of patients: A. Patients with low versus high risk of endocarditis according with the "Number of positive blood cultures, Origin of the bacteremia, previous Valve disease, Auscultation of heart murmur (NOVA) score". B. Patients with metastatic septic localizations. C. Patients with catheter-related BSI. D. Patients with indwelling cardiovascular device or prosthetic valve. 3. To validate the NOVA score as a predictor of enterococcal endocarditis in a large multicentre cohort of patients with EF-BSI. 4. To estimate optimal duration of treatment of EF-BSI in patients without endocarditis. 5. To evaluate the rate of 90-day development of Clostridium difficile infection. The promoting center is S. Orsola-Malpighi Hospital is a 1,420-bed tertiary care University Hospital in Bologna with an average of 72,000 admissions per year. A dedicate team of Infectious Diseases (ID) specialists is active in the promoting center. Investigators of this team have already coordinated multicenter studies on infections topics. Centers from other countries will be invited to participate by email, they will be ask to fulfil an agreement form. All consecutive, unselected patients with monomicrobial EF-BSI will be screened for study inclusion. We expect to enroll about 500 patients. Period of data collection will be from september 2019 to 31th December 2020.

NCT ID: NCT03991793 Not yet recruiting - Sepsis Clinical Trials

Granzyme A in Patients With E. Coli Bacteremic Urinary Tract Infections

GABEC
Start date: June 20, 2019
Phase:
Study type: Observational

Background: Survival in Granzyme A gene (gzmA) knocked-out mice was significantly longer than in wild-type mice in a murine peritonitis model (cecal ligation puncture). Hypothesis: GZM A has a pathogenic role in sepsis in humans and gzmA polymorphisms can help to predict the risk of sepsis among patients with systemic infections (E. coli bacteremic urinary tract infections). Objectives: 1. To assess the correlation between GZM A serum levels and systemic inflammatory response in a human model of infection/sepsis (E. coli bacteremic UTI) 2. To characterize gzmA polymorphisms among patients with E. coli bacteremic UTI 3. To determine GZM A serum kinetics among patients with E. coli bacteremic UTI 4. To characterize E. coli strains causing bacteremic UTI: antimicrobial phenotype and virulence factors ("virulome"). Methods: - Design and setting: Prospective nested case-control study - Study population: consecutive adult patients with bacteremic urinary tract infections (UTIs) caused by E. coli - Exclusion criteria: Patients with conditions that significantly compromise immune status or patients exposed to urologic procedures - Estimated sample size: 50 patients with a sepsis/ non sepsis 1:1 ratio. Septic and non septic patients will be matched on gender, age (+/- 10 years), comorbidity (Charlson score +/-1), time symptom onset to blood culture (+/- 24h) - Measurements: GZM A serum levels will be determined on day 0, day 2-3, day 30. GZM A kinetics, gzmA polymorphisms (whole exome sequencing).Whole genome sequencing of E. coli isolates retrieved from blood cultures will be performed. - Analysis: Association between GZM A levels and gzmA polymorphisms and sepsis will be analyzed adjusting for patient, infection and microorganism-related factors (multivariate analysis).

NCT ID: NCT03896893 Recruiting - Prematurity Clinical Trials

Neonatal Bacterial Colonization Study

Start date: March 4, 2019
Phase: N/A
Study type: Interventional

This study will evaluate the effect of skin antisepsis and/or emollient therapy on bacterial colonization dynamics in very low birth weight, hospitalized infants. Bacterial swabs from 5 body sites will be collected at baseline, day 3, day 8 and day 13 following study arm assignment. Study outcomes include changes in bacterial colony counts, burden of gram-negative and gram-positive pathogens and overall skin score.

NCT ID: NCT03896880 Completed - Clinical trials for Bloodstream Infection

Detection of Bloodstream Pathogens in Hematological Malignancies

Start date: January 1, 2020
Phase:
Study type: Observational

- To identify the common bacterial and fungal species causing fungemia and bacteremia in hematological malignancies. - To identify sensitivity pattern for causative microbes. - Compare culture on ordinary media with Vitek2 (automated microbial identification system) and multiplex polymerase chain reaction (PCR )

NCT ID: NCT03744728 Active, not recruiting - Clinical trials for Bloodstream Infection

Genotypic Versus Phenotypic Susceptibility Testing of Positive Blood Cultures

Start date: May 23, 2019
Phase: N/A
Study type: Interventional

This study is designed as a prospective, randomized, open-label trial evaluating antimicrobial utilization, clinical outcomes, and healthcare costs among patients with positive blood cultures. Patients will be randomized to one of the following FDA-cleared devices that will be used to assess the workflow impact of fast identification (ID) and antimicrobial susceptibility testing (AST) in the microbiology lab and in the quality of care in patients: 1) Standard culture and AST of positive blood culture bottles plus the Verigene® Blood Culture Gram-positive/Gram-negative kit (BC-GP/GN); or 2) Fast ID and AST of positive blood culture bottles using the Accelerate PhenoTestâ„¢ BC kit with the Accelerate Phenoâ„¢ System.

NCT ID: NCT03578835 Recruiting - Septic Shock Clinical Trials

Bloodstream Infection Due to Multidrug-Resistant Organisms - Multicenter Study on Determinants of Clinical Outcomes

BLOOMY-COM
Start date: February 1, 2017
Phase:
Study type: Observational [Patient Registry]

Continual surveillance of both community-acquired and nosocomial bloodstream infections for specific target organisms. Analysis of comorbidities, complications, bacterial resistance patterns, bacterial genomics (e. g. via WGS and MLST typing) for the determinants of clinical outcomes. The clinical outcomes are investigated both in the short-term (up until discharge) and the long-term (six months after index blood culture by standardized questionnaire). A predictive point-of-care score is to be developed based on these data to define high-risk patient populations requiring more intensive diagnostic and/or treatment regimens.

NCT ID: NCT03255759 Completed - Clinical trials for Bloodstream Infection

Actionable Results: Bloodstream Infection Molecular Assay Evaluation

Start date: May 24, 2018
Phase: N/A
Study type: Interventional

A number of rapid panel-based molecular assays for direct organism identification and resistance characterization in positive blood culture bottles are now commercially available. They have been shown to improve accuracy and decrease the time-to-result, allowing targeted treatment in hospitalized patients with bacteraemia, in high-income countries (HICs). However, these molecular assays are add-on tests performed in addition to conventional testing, increasing the complexity of diagnostic algorithms and costs of patient care. Conventional organism identification includes performing a Gram stain, biochemical identification and phenotypic drug susceptibility testing. The FilmArray Blood Culture Identification (BioFire, USA) is an example of a rapid panel-based molecular assay that combines nesting and multiplexing of PCR (nested multiplex PCR) to detect multiple pathogens simultaneously. There are limited data on how such tests impact patient management, health care costs and how they can better be incorporated into diagnostic algorithms. The aim of this study is to assess the added value and acceptability of a multiplexed molecular diagnostic assay in the identification of pathogens in patients presenting with bacteremia at hospitals in LMICs, and to assess health care providers' satisfaction with the assay.