Cefepime, enmetazobactam (Exblifep) - To treat complicated urinary tract infections Skip to main contentSkip to FDA SearchSkip to footer links An official website of the United States government Here's how you know U.S. Food and Drug Administration Search MenuSearch FDASubmit search Home Drugs Drug Approvals and Databases Drugs@FDADrug Approval Package
In adult patients with sepsis without an indication for anaerobic coverage, does empirical antibiotic therapy with vancomycin plus piperacillin/tazobactam increase 90-day mortality compared with vancomycin plus cefepime? www.annemergmed.com Verify you are human by completing the action below. www.annemergmed.com needs to review the security of your connection before proceeding.Ray ID
Cefepime-enmetazobactam for treating hospital-acquired pneumonia including ventilator-associated pneumonia Cefepime-enmetazobactam for treating hospital-acquired pneumonia including ventilator-associated pneumonia - NIHR Innovation Observatory * Who we are * What we do * Our Networks * Engage * Events * News * Resources Get in touch * * A world leading Horizon Scanning Facility The NIHR MedicinesMarch 2024 * Who we are * Meet the Team * Our Mission * Our Values * What we do * Emerging horizon * Transitional horizon * Imminent horizon * Our Networks * Our Stakeholders * Our Work with NICE * Health & Life Sciences Ecosystem * Engage * Industry * Public Involvement * Capacity Building * Events * News * Resources * Contact 22 April 2024 Cefepime-enmetazobactam for treating hospital-acquired
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Cefepime-Taniborbactam in Complicated Urinary Tract Infection. Carbapenem-resistant Enterobacterales species and multidrug-resistant are global health threats. Cefepime-taniborbactam is an investigational β-lactam and β-lactamase inhibitor combination with activity against Enterobacterales species and expressing serine and metallo-β-lactamases. In this phase 3, double-blind, randomized trial , we assigned hospitalized adults with complicated urinary tract infection (UTI), including acute pyelonephritis, in a 2:1 ratio to receive intravenous cefepime-taniborbactam (2.5 g) or meropenem (1 g) every 8 hours for 7 days; this duration could be extended up to 14 days in case of bacteremia. The primary outcome was both microbiologic and clinical success (composite success) on trial days 19 to 23
In complicated UTIs, cefepime-taniborbactam increased treatment success vs. meropenem at 19 to 23 d. Wagenlehner FM, Gasink LB, McGovern PC, et al; CERTAIN-1 Study Team. N Engl J Med. 2024;390:611-622. 38354140.
Outcomes associated with empiric cefepime for bloodstream infections caused by ceftriaxone-resistant, cefepime-susceptible Escherichia coli and Klebsiella pneumoniae. Cefepime is a first-line agent for empiric sepsis therapy; however, cefepime use may be associated with increased mortality for extended-spectrum beta-lactamase-producing Enterobacterales (ESBL-E) in an MIC-dependent manner . This study aimed to compare the efficacy of empiric cefepime versus meropenem for bloodstream infections (BSI) caused by ceftriaxone-resistant Escherichia coli and Klebsiella pneumoniae with cefepime MICs ≤ 2 mg/L. This single-center retrospective cohort study included patients admitted from October 2010 to August 2020 who received cefepime or meropenem empirically for sepsis with a blood culture growing
In vitro activity of cefepime/zidebactam and cefepime/taniborbactam against aztreonam/avibactam-resistant NDM-like-producing Escherichia coli clinical isolates. Aztreonam/avibactam is one of the last therapeutic options for treating infections caused by NDM-like-producing Enterobacterales. However, PBP3-modified and NDM-producing Escherichia coli strains that co-produce CMY-42 have been shown to be resistant to this drug combination. The aim of our study was to assess the in vitro activity of cefepime/taniborbactam and cefepime/zidebactam against such aztreonam/avibactam-resistant E. coli strains. MIC values of aztreonam, aztreonam/avibactam, cefepime, cefepime/taniborbactam, cefepime/zidebactam and zidebactam alone were determined for 28 clinical aztreonam/avibactam-resistant E. coli isolates
In vivo pharmacokinetic/pharmacodynamic evaluation of cefepime/taniborbactam combination against cefepime-non-susceptible Enterobacterales and Pseudomonas aeruginosa in a murine pneumonia model. Cefepime/taniborbactam is a cephalosporin/bicyclic boronate β-lactamase inhibitor combination in clinical development for nosocomial pneumonia due to MDR Gram-negative bacteria. A murine pneumonia model was used to characterize cefepime/taniborbactam in vivo pharmacodynamics against Enterobacterales and Pseudomonas aeruginosa strains. Clinical cefepime-non-susceptible Enterobacterales and P. aeruginosa strains expressing serine carbapenemases and/or other cefepime-hydrolysing β-lactamases with cefepime/taniborbactam combination MICs of 0.12-16 mg/L were used. Cefepime and taniborbactam human-simulated
Cefepime in vivo activity against carbapenem-resistant Enterobacterales that test as cefepime susceptible or susceptible-dose dependent in vitro: implications for clinical microbiology laboratory and clinicians. Carbapenem-resistant Enterobacterales (CRE) are a public health concern. Among these isolates, there are reports of isolates that test as cefepime susceptible or susceptible-dose dependent (SDD) in vitro despite presence of a carbapenemase. This study aimed to evaluate the pharmacokinetic/pharmacodynamic profile of cefepime against carbapenemase-producing (CP-CRE) and non-producing (non-CP-CRE) isolates with a range of cefepime MICs. Reference broth microdilution and modified carbapenem inactivation method (mCIM) were performed on genotypically characterized clinical CRE isolates
The ACORN Trial: Battle of the Gorilla-Cillins (Cefepime vs Piperacillin-Tazobactam) This site is currently undergoing scheduled maintenance.Please try back soon!
Urinary Biomarkers and Attainment of Cefepime Therapeutic Targets in Critically Ill Children. Critically ill children are at risk for subtherapeutic antibiotic concentrations. The frequency of target attainment and risk factors for subtherapeutic concentrations of cefepime in children have not been extensively studied. We performed an observational study in critically ill children receiving a new prescription of standard dosing of cefepime for suspected sepsis (≥2 systemic inflammatory response syndrome criteria within 48 hours of cefepime start). Three plasma cefepime concentrations were measured at steady state and, a urine sample was collected prior to pharmacokinetics (PK) sampling for measurement of urinary biomarkers. Bayesian analysis determined cefepime PK for each individual
Comparative evaluation of disc diffusion and Liofilchem™ MTS strip methods with broth microdilution for cefepime/enmetazobactam susceptibility testing. Cefepime/enmetazobactam is a newly approved β-lactam/β-lactamase inhibitor combination with promising activity against MDR Gram-negative Enterobacterales, particularly ESBL- and OXA-48-producing isolates. Reliable susceptibility testing methods are essential to guide its clinical use. To evaluate the performance of two commercial cefepime/enmetazobactam susceptibility testing methods, disc diffusion and Liofilchem™ MTS gradient strips, using broth microdilution (BMD) as the gold standard. A total of 291 carbapenem-resistant Enterobacterales isolates, including 194 carbapenemase producers, were included. Susceptibility testing was performed using BMD
Cystatin C-Guided Dosing Nomogram Improves Target Attainment for Cefepime in the Critically Ill. Estimated glomerular filtration rate is more accurate with combined creatinine and cystatin C equations (eGFRcr-cys) than creatinine alone. This study created and evaluated a cefepime dosing nomogram based on eGFRcr-cys for initial dosing in the critically ill. Pharmacokinetic modeling and simulation study. Academic medical center. Critically ill adults treated with cefepime. None. Data from 120 patients with baseline cystatin C and follow-up cefepime levels were used to develop a nomogram based on eGFRcr-cys and weight for initial cefepime dosing. The predicted proportion of patients who achieved a free cefepime concentration above the minimum inhibitory concentration of the organism for 100
Restoring cefepime activity against multidrug-resistant KPC-producing Klebsiella pneumoniae by combination with boronic acid inhibitors, MB076 and S02030. Foremost in the design of new β-lactamase inhibitors (BLIs) are the boronic acid transition state inhibitors (BATSIs). Two highly potent BATSIs being developed are S02030 and MB076 strategically designed to be active against cephalosporinases and carbapenemases, especially KPC. When combined with cefepime, S02030 and MB076 demonstrated potent antimicrobial activity against laboratory and clinical strains of expressing a variety of class A and class C β-lactamases, including and . Static time-kill assays revealed the bactericidal activity of cefepime in combination with S02030 and MB076 against a multidrug-resistant KPC-producing (KPC--1), in which
Decreased susceptibility to cefepime/zidebactam among carbapenemase-producing Escherichia coli from Stockholm, Sweden with alterations in PBP2. We aimed to investigate the in vitro activity and genetic determinants of decreased susceptibility (DS; MIC > 4 mg/L) to cefepime/zidebactam of carbapenemase-producing Escherichia coli. Clinical isolates (N = 150) of carbapenemase-producing E. coli (CP -EC) belonging to seven distinct STs, isolated at a university clinical microbiology laboratory during 2019-2023 in Stockholm, Sweden were included. MICs for cefepime/zidebactam were determined using the broth microdilution method and interpreted using the tentative EUCAST clinical breakpoints (Susceptible; MIC < 4 mg/L; based on cefepime breakpoint). Whole genome sequences of the isolates were
Cefepime-taniborbactam and ceftibuten-ledaborbactam maintain activity against KPC variants that lead to ceftazidime-avibactam resistance. carbapenemases (KPCs) are widespread β-lactamases that are a major cause of clinical non-susceptibility of Gram-negative bacteria to carbapenems and other β-lactam antibiotics. Ceftazidime combined with the β-lactamase inhibitor avibactam (CAZ-AVI) has been effective in treating infections by KPC-producing bacteria, but emerging KPC variants confer resistance to the combination. Taniborbactam and ledaborbactam are bicyclic boronate β-lactamase inhibitors currently under development with cefepime and ceftibuten, respectively, to treat carbapenem-resistant bacterial infections. Here, we assessed the effects of clinically important KPC-2 and KPC-3 variants
Cefepime versus carbapenem for treating complicated urinary tract infection caused by cefoxitin-nonsusceptible ESCPM organisms: a multicenter, real-world study. This investigation aimed to compare the efficacy of cefepime and carbapenem for complicated urinary tract infection (cUTI) caused by presumptive AmpC β-lactamase-producing Enterobacter spp., Serratia marcescens, Citrobacter freundii , Providencia spp., and Morganella morganii (ESCPM). Data of 458 individuals with cUTI caused by cefoxitin-nonsusceptible [minimum inhibitory concentration (MIC) > 8 µg/mL] and cefepime-susceptible (MIC ≤ 2 µg/mL) ESCPM was acquired from four Chinese hospitals between 2010 and 2022 and were reviewed retrospectively. 125 and 333 patients received cefepime and carbapenems, respectively, as antimicrobial therapy
Impact of porin deletions on cefepime-taniborbactam activity against Klebsiella pneumoniae. We determined the frequency of resistance to cefepime-taniborbactam in NDM-1-producing at <10. Isolated mutants that were less susceptible to cefepime-taniborbactam had an increased copy number of the gene or disruption of major porins OmpK36 and OmpK35. Antibacterial susceptibility testing using isogenic strains indicated that while cefepime penetrates into the periplasm mainly through the major porins, taniborbactam does not have a strong dependence on OmpK35 or OmpK36 for periplasmic accumulation.
Spectrum of cefepime-taniborbactam coverage against 190 β-lactamases defined in engineered isogenic Escherichia coli strains. Cefepime-taniborbactam is a β-lactam/β-lactamase inhibitor combination in clinical development for the treatment of Enterobacterales and infections, including carbapenem-resistant Enterobacterales and multidrug-resistant . Taniborbactam is a novel cyclic boronate with direct inhibitory activity against clinically relevant Ambler class A, B, C, and D β-lactamases. To further characterize the spectrum of β-lactamase coverage by cefepime-taniborbactam, we constructed 190 isogenic strains of that constitutively expressed a different β-lactamase. Synthetic codon-optimized genes encoding the mature periplasmic protein linked to the TEM-1 signal sequence were used