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Bacteremia clinical trials

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NCT ID: NCT06080698 Recruiting - Clinical trials for Gram-negative Bacteremia

Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial

GOAT
Start date: February 22, 2024
Phase: N/A
Study type: Interventional

The Gram-negative bloodstream infection Oral Antibiotic Therapy trial (The GOAT Trial) is a multi-center, randomized clinical trial that hypothesizes that early transition to oral antibiotic therapy for the treatment of Gram-Negative BloodStream Infection (GN-BSI) is as effective but safer than remaining on intravenous (IV) antibiotic therapy for the duration of treatment.

NCT ID: NCT06069206 Recruiting - Clinical trials for Bloodstream Infection

Effect of Direct-from-blood Bacterial Testing on Antibiotic Administration and Clinical Outcomes

Start date: December 13, 2023
Phase: N/A
Study type: Interventional

Bacterial blood stream infections are common and life-threatening. Bloodstream infections have historically been identified using blood cultures, which often take 24-72 hours to result and are imperfectly sensitive. Early administration of antimicrobial therapy is a fundamental component of the management of adults presenting to the hospital with a suspected bloodstream infection and/or sepsis. But because blood cultures frequently take 24-72 hours to result, patients are typically treated with empiric, broad spectrum antibiotics. In a meta-analysis of sepsis studies, empirical antibiotic therapy was inappropriate for the organism that ultimately grew in culture in almost half of patients. Thus, patients are commonly exposed to unnecessary antibiotics without evidence of infection or with evidence of infection requiring narrow antibiotic selection. For example, current guidelines recommend the use of empiric intravenous vancomycin as coverage for a bloodstream infection caused by the bacterial pathogen methicillin-resistant S. aureus (MRSA). Vancomycin requires careful monitoring due to its narrow therapeutic range and high risk of toxicity. Administration of vancomycin to patients who do not have MRSA can lead to avoidable adverse drug events and costs, as well as drive antimicrobial resistance. There has been increasing interest in using rapid diagnostic tests that identify bacteria directly from whole blood samples without relying on growth in culture, referred to as "direct-from-blood" tests, to guide early therapeutic management of patients with suspected bloodstream infections in addition to standard blood cultures. One such FDA-approved, direct-from-blood test is the T2Bacteria® Panel. This panel's performance as a direct-from blood test for bacterial pathogens has been described in previous studies. A recent meta-analysis of largely observational studies reported a faster transition to targeted microbial therapy and de-escalation of empirical microbial therapy, as well as a shorter duration of intensive care unit stay and hospital stay for patients who received this direct-from-blood test. We will conduct a pragmatic, randomized clinical trial examining the effect of using the T2Bacteria® Panel direct from-blood testing, compared to using blood cultures alone (standard of care), on antimicrobial receipt and clinical outcomes for adults presenting to the hospital with suspected infection and who have been initiated on empiric therapy with intravenous vancomycin.

NCT ID: NCT05975671 Recruiting - Sepsis Clinical Trials

Reducing Empiric VAncomycin Use in Pediatric Suspected Sepsis

REVAMP
Start date: August 21, 2023
Phase: N/A
Study type: Interventional

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). There are two groups of subjects in this study: PICU clinicians/sepsis stakeholders and patients admitted to one of the participating PICUs during the study period. The intervention will at a minimum include: - Implementation of a clinical guideline indicating when vancomycin should and should not be used - Unit-level feedback on overall vancomycin use within and across centers - Clinician education.

NCT ID: NCT05950984 Recruiting - Sepsis Clinical Trials

Medical Device (MD) Derived Pharmacokinetic (PK) Parameters for Vancomycin (MD-PK)

MD-PK
Start date: October 30, 2023
Phase:
Study type: Observational

Getting the right dose of antibiotic promptly is an important part of treating infections. Unfortunately, when an infection is severe (sepsis) the body changes how it processes antibiotics. Consequently, some people with severe infection retain antibiotics for too long (risking adverse effects), whilst others excrete antibiotics too quickly (risking under-treatment). Mathematical models can help researchers understand drug handling variability (known as pharmacokinetics) between people. These models require very accurate information about drug administration and drug blood concentration timings. Researchers usually rely on someone recording these timings, but recording errors can make models inaccurate. We would like to understand if using data from routinely used electronic drug infusion devices (recording the exact time of administration) can improve the accuracy of pharmacokinetic models. We intend to investigate this with an antibiotic (vancomycin) that clinicians already routinely monitor blood concentrations for. Adults and children treated at St George's Hospital intensive care units will be invited to participate in the study which will last for 28-days within a 14-month period. Participants will donate a small amount of extra blood and provide researchers access to their clinical data. Blood will be taken at special times during vancomycin treatment from lines placed as part of standard treatment, minimising any pain or distress. There will be no other changes to patient's treatment. In the future, data from this study might help change the way we dose antibiotics. The National Institute for Health and Care Research and Pharmacy Research UK are supporting the study with funding.

NCT ID: NCT05893147 Recruiting - Clinical trials for Gram-negative Bacteremia

BALANCE+ Vanguard Phase

BALANCE+
Start date: August 26, 2023
Phase: N/A
Study type: Interventional

The goal of the BALANCE+ clinical trial is to transform random care to randomized care for patients with Gram negative bloodstream infections to inform best treatment approaches and optimize outcomes. BALANCE+, a perpetual platform trial, will efficiently answer multiple questions that are important for hospitalized patients with Gram negative bloodstream infections.

NCT ID: NCT05862025 Recruiting - Clinical trials for Infective Endocarditis

Evaluation of the Usefulness of Echocardiography in Patients With Staphylococcus Aureus Bacteremia (ET-AUREUS Study).

ET-AUREUS
Start date: September 4, 2023
Phase: N/A
Study type: Interventional

The goal of this prospective interventionist cohort study is to assess the prevalence of infective endocarditis in patients with Staphylococcus aureus bacteremia at low risk of this complication. The main questions it aims to answer are: - Determine whether the risk of infective endocarditis in patients with Staphylococcus aureus bacteriemia identified as low-risk, using the VIRSTA score, is low enough to safely omit transthoracic or transesophageal echocardiography. - Determine whether the risk of infective endocarditis in patients with Staphylococcus aureus bacteriemia in patients with no identifiable risk factor is low enough to safely omit transthoracic or transesophageal echocardiography. - Calculate a cost-benefit estimate of omitting echocardiographic testing in patients identified as low-risk by means of the above methods. Participants will undergo mandatory transthoracic and transesophageal echocardiography during the first 2 weeks from Staphylococcus aureus bacteremia onset.

NCT ID: NCT05741424 Recruiting - Bacteremia Clinical Trials

Impact of BacT/Alert® VIRTUO®, BioFire® Blood Culture Identification 2-BCID2 and REVEAL® (bioMérieux) on the Optimization of Antibiotic Therapy for Gram-negative Bacteremia in the ICU

BacteREVEAL
Start date: March 8, 2023
Phase:
Study type: Observational

Bacteremia is a frequent infection in intensive care units. It is associated with a high mortality rate and the rapid implementation of appropriate antibiotic therapy is strongly correlated to patient clinical outcomes. Innovative technologies have emerged to shorten the turnaround time of blood culture samples by obtaining susceptibility testing of the incriminated pathogen at an early stage, and therefore to rapidly adjust the antibiotic therapy of patients with Gram-negative Bacilli bacteremia. The study investigators hypothesize that the implementation of the innovative BacT/Alert® VIRTUO®, BioFire® BCID2 and REVEAL® solutions for the analysis of blood culture samples will increase the proportion of patients with Gram-negative Bacilli bacteremia who receive appropriate and optimized antibiotic therapy 24 hours after blood culture collection.

NCT ID: NCT05721781 Recruiting - Bacteremia Clinical Trials

Reducing Risk for Infective Endocarditis

PIE-B
Start date: August 31, 2023
Phase: N/A
Study type: Interventional

This clinical trial is studying if bacteria found in a participant's bloodstream after brushing their teeth can be prevented with a dental cleaning and more education on how to best brush and care for their teeth. One group of participants will have a dental cleaning and oral health instructions and the other group of participants will not. Researchers will compare the blood test results from the two groups to see if the education made a difference in preventing bacteria and how long it stays in the bloodstream.

NCT ID: NCT05613322 Recruiting - Bacteremia Sepsis Clinical Trials

Resistell Phenotech AST to Determine the Antibiotic Susceptibility of Gram-negative Bacteria Causing Bacteremia

PHENOTECH-1
Start date: January 18, 2023
Phase:
Study type: Observational

The aim of this study is to assess the sensitivity, specificity, and accuracy of the Resistell Phenotech device in testing antibiotic susceptibility of Gram-negative bacteria (i.e., E. coli or K. pneumoniae) to clinically relevant antibiotics. The study is designed as a prospective, non-interventional, multi-center, single-arm study. The blood culture samples from bacteremia patients that are positive for E. coli or K. pneumoniae will be tested with the Resistell Phenotech device after strain identification by MALDI-TOF. The results of the Resistell AST will be compared with the results from the disk diffusion tests (all sites use the Kirby-Bauer disk diffusion test), and site dependent tests (VITEK® 2, BD Phoenix™, MicroScan WalkAway system, and/or EUCAST RAST), which are currently the standard AST methods in the microbiology laboratories at the participating sites.

NCT ID: NCT05394298 Recruiting - Clinical trials for Enterococcal Bacteremia

Short vs Long of Usual Treatment for Non Complicated Enterococcal Bacteremia

INTENSE
Start date: July 11, 2022
Phase: Phase 4
Study type: Interventional

Randomized clinical trial to determine the optimal duration of antibiotic treatment for E. Faecalis or E. faecium bacteraemia, following an innovative DOOR / RADAR (Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR)) analysis methodology. Phase IV clinical trial, open-labelled, randomized, pragmatic, multicenter study to demonstrate non-inferiority of a 7-day antibiotic regimen vs. 14 days in the treatment of bacteremia due to E. faecalis or E. faecium.