Antimicrobial Resistant Organism Decolonization After Microbiome Perturbation (ARO-DECAMP): a Multi-centre, Randomized, Placebo-controlled Feasibility Pilot Trial

ARO-DECAMP is a multi-centre, placebo-controlled, pilot and feasibility randomized controlled trial for the microbial consortium Microbial Ecosystem Therapeutic-2. Non-intensive care unit patients ≥ 18 years old diagnosed with a bloodstream infection and receiving treatment for an antibiotic resistant organism will be included. Participants will be randomized to receive either MET-2 or placebo for 10 days. Recruitment rate and study intervention adherence will be evaluated for feasibility. Participants will be followed for 180 days, and biological samples will be collected periodically for clinical, ecological, and biomarker outcomes.

Start Date01 Jul 2024

Sponsor / Collaborator

University Health Network

NCT06537609 / RecruitingNot ApplicableIIT

BALANCE+: A Platform Trial for Gram Negative Bloodstream Infections

BALANCE+ is a perpetual multiple domain randomized controlled platform trial to evaluate various treatment strategies for Gram-negative bloodstream infections (GN BSIs). Each domain addresses critical questions in the management of GN BSIs, aiming to refine treatment strategies, enhance patient outcomes, and reduce antimicrobial resistance.
The initial vanguard pilot RCT (NCT05893147) started on 29 August 2023 and has successfully completed the pilot phase on 24-Apr-2024. All patients enrolled in the vanguard phase are part of the main platform trial.

Start Date24 Apr 2024

Sponsor / Collaborator

Sunnybrook Health Sciences Centre

[+1]

NCT06080698 / RecruitingNot ApplicableIIT

Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial

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.

Start Date22 Feb 2024

Sponsor / Collaborator

The Johns Hopkins University

[+1]

100 Clinical Results associated with Gram-negative bacteremia

100 Translational Medicine associated with Gram-negative bacteremia

0 Patents (Medical) associated with Gram-negative bacteremia

1,731

Literatures (Medical) associated with Gram-negative bacteremia

31 Dec 2024·Epigenetics

IL21R hypomethylation as a biomarker for distinguishing benign and malignant breast tumours

Article

Author: Yang, Rongxi ; Zhu, Qiang ; Zang, Zishan ; Liu, Chunlan ; Li, Hong ; Yin, Yifei ; Huang, Xuandong

Some benign and malignant breast tumours are similar in pathological morphology, which are difficult to be distinguished in clinical diagnosis. In this study, we intended to explore novel biomarkers for differential diagnosis of benign and malignant breast tumours. Methylation EPIC 850K beadchip and RNA-sequencing were used to analyse 29 tissue samples from patients with early-stage breast cancer (BC) and benign breast tumours for differently methylated and expressed genes. The altered methylation of IL21R was semi-quantitatively validated in an independent study with 566 tissue samples (279 BC vs. 287 benign breast tumours) using mass spectrometry. Binary logistic regression analysis was performed to evaluate the association between IL21R methylation and BC. BC-associated IL21R hypomethylation and overexpression were identified in the discovery round. In the validation round, BC patients presented significant IL21R hypomethylation compared to women with benign breast tumours (ORs ≥1.29 per-10% methylation, p-values ≤ 5.69E-14), and this hypomethylation was even enhanced in BC patients with ER-negative and PR-negative tumours as well as with triple-negative tumours. The methylation of IL21R showed efficient discriminatory power to distinguish benign breast tumours from BC (area under curve (AUC) = 0.88), and especially from ER-negative BC (AUC = 0.95), PR-negative BC (AUC = 0.93) and triple-negative BC (AUC = 0.96). We disclosed significant IL21R hypomethylation in patients with BC compared to women with benign breast tumours, and revealed the somatic change of DNA methylation could be a potential biomarker for molecular pathology of BC.

03 Oct 2024·Microbiology Spectrum

Evaluation of the quickmic system in the rapid diagnosis of Gram-negative bacilli bacteremia

Article

Author: Tyshkovska-Germak, Iryna ; Ricart-Silvestre, Andrea ; Merino, Esperanza ; Ventero, María Paz ; Parra Grande, Mónica ; Sánchez-Bautista, Antonia ; Rodríguez, Juan Carlos ; García-Rivera, Celia

ABSTRACT Rapid microbiological diagnosis of the antibiotic susceptibility of Gram-negative bacilli is a priority in clinical microbiology, especially in cases of bacteremia. The rapid advancement of antimicrobial resistance proposes a challenge for empirical antibiotic therapy and shows the need for fast antibiotic susceptibility diagnostics to guide treatments. The QuickMIC System (Gradientech AB, Uppsala, Sweden) is a recently developed rapid diagnostic tool for antibiotic susceptibility testing. Our study evaluates a rapid phenotypic system (QuickMIC) that provides information on the susceptibility of 12 antibiotics against Escherichia coli , Klebsiella spp ., Pseudomonas aeruginosa , Acinetobacter baumannii , Enterobacter cloacae , Proteus spp ., Citrobacter spp., and Serratia marcescens . A total of 816 antibiotic/microorganism combinations were tested, resulting in eight discrepancies. The concordance between the antibiotics offered by QuickMIC and reference methods (MicroScan WalkAway plus system, Beckman Coulter; Etest (BioMerieux microdilution system (Bruker); Real-time PCR (GeneXpert, Cepheid); and immunochromatography (Biotech) was 99.02%. Time elapsed to obtain a valid minimal inhibitory concentration (MIC) was between 2 and 4 h. The QuickMIC system allows for the early adjustment of antibiotic treatment in these infections. Given the existing limitations of currently available rapid methods, its clinical utility is particularly relevant in the management of P. aeruginosa infections and AmpC-producing Enterobacterales. The use of rapid methods can help diversify antibiotic use and reduce carbapenem consumption. IMPORTANCE The rapid diagnosis of antibiotic sensitivity in Gram-negative bacilli is of paramount importance in clinical microbiology, particularly in cases of bacteremia. The escalating challenge of antimicrobial resistance underscores the need for expeditious antibiotic susceptibility diagnostics to guide empirical antibiotic therapy effectively. In light of this, we present our study that evaluates the QuickMIC System, a recently developed rapid diagnostic antibiogram. QuickMIC System, offers a novel approach to phenotypic testing, providing information on the activity of 12 antibiotics against key pathogens, including Escherichia coli , Klebsiella spp ., Pseudomonas aeruginosa , Acinetobacter baumannii , Enterobacter cloacae , Proteus spp ., Citrobacter spp ., and Serratia marcescens . Our investigation involved testing a total of 816 antibiotic/microorganism combinations. The study demonstrated an impressive 99.02% concordance between the QuickMIC System and the reference methods, with only eight discrepancies observed. The time to actionable minimum inhibitory concentration (MIC) ranged between 2 and 4 h, highlighting the system's efficiency in providing rapid results.

01 Oct 2024·JAC-antimicrobial resistance

Risk factors for positive follow-up blood cultures in critically ill adults with Gram-negative bacteraemia.

Article

Author: Mayes, Rebecca A ; McCloskey, Cindy B ; White, Bryan P ; Siegrist, Emily A ; Mathew, Julia ; Neely, Stephen B

ObjectivesTo evaluate the utility of follow-up blood cultures (FUBCs) for Gram-negative bloodstream infection (BSI) in ICU patients and identify risk factors for repeat positive cultures.MethodsThis was a single-centre, retrospective cohort study of critically ill adults with Gram-negative BSI between 1 January 2015 and 1 January 2020. Critically ill patients with one or more blood cultures positive for a Gram-negative organism were included. Descriptive and inferential statistics were performed with an alpha of 0.05.ResultsA total of 148 critically ill patients with Gram-negative BSI were included, with 42 patients (28.4%) having one or more positive FUBCs. The majority (66.2%) were admitted to a medical ICU. The most common organisms isolated were Escherichia coli (n = 56, 37.8%) and Klebsiella pneumoniae (n = 26, 17.6%). Significant patient risk factors associated with a positive FUBC on univariate regression included: MDR organisms, immunocompromised status, fever, vasopressor use at time of FUBC, lack of source control attainment, and higher quick Pitt bacteraemia score. Multivariable penalized logistic regression indicated that lack of source control containment and less time from index to FUBC remained significantly associated with repeat positive FUBC.ConclusionsThis is the first study to investigate the use of FUBC for Gram-negative BSI in exclusively ICU patients. Risk factors for repeat positive FUBC in this population include lack of source control and less time between index and FUBC. Prospective studies are needed to fully elucidate the role of FUBCs in critically ill patients with Gram-negative BSI.

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