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- | imipenem/relebactam / Merck (MSD)
Trial completion date, Trial primary completion date: Imipenem-Relebactam Pharmacokinetics in Augmented Renal Clearance (clinicaltrials.gov) - Feb 15, 2021
P1, N=12, Recruiting, Sponsor: Hartford Hospital
Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Nov 2020 --> Nov 2021
- || relebactam (MK-7655) / Merck (MSD)
Clinical, Journal: RESTORE-IMI 1: A Multicenter, Randomized, Double-blind Trial Comparing Efficacy and Safety of Imipenem/Relebactam vs Colistin Plus Imipenem in Patients With Imipenem-nonsusceptible Bacterial Infections. (Pubmed Central) - Jan 8, 2021
P3
Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Nov 2020 --> Nov 2021 Imipenem/relebactam is an efficacious and well-tolerated treatment option for carbapenem-nonsusceptible infections.
- || imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
Clinical, Journal: Activity of imipenem/relebactam against a large collection of Pseudomonas aeruginosa clinical isolates and isogenic β-lactam resistant mutants. (Pubmed Central) - Jan 6, 2021
Imipenem/relebactam showed highest susceptibility rates (97.3%), followed by colistin and ceftolozane/tazobactam (both 94.6%). Imipenem/relebactam MICs remained ≤2 μg/mL in all 16 isogenic PAO1 mutants and in 8 pairs of XDR clinical strains that had developed resistance to ceftolozane/tazobactam and ceftazidime/avibactam due to mutations in OXA-10 or AmpC.
- || imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
Clinical, Review, Journal: A Clinical Review and Critical Evaluation of Imipenem-Relebactam: Evidence to Date. (Pubmed Central) - Dec 5, 2020
The most common adverse drug events associated with I-R were nausea (6%), diarrhea (6%), and headache (4%). I-R is a new beta-lactam/beta-lactamase inhibitor combination that will be most likely used for patients with multidrug-resistant gram-negative infections in which there are limited or no available alternative treatment options.
- | Recarbrio (relebactam/imepenem/cilastatin) / Merck (MSD)
Journal: Evaluating imipenem + cilastatin + relebactam for the treatment of complicated urinary tract infections. (Pubmed Central) - Nov 18, 2020
Further studies upon these specific groups of UTI patients are needed including additional pharmacokinetic studies upon its tissue penetration of the prostate which is currently unknown. However, in our opinion, imipenem/relebactam can be used in complicated UTI when other treatment options are limited.
- | imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
Journal: In vitro activity of imipenem-relebactam and key β-lactam agents against Gram-negative bacilli isolated from lower respiratory tract infection samples of intensive care unit patients - SMART Surveillance United States 2015-2017. (Pubmed Central) - Oct 10, 2020
Generally, only slight variations in susceptibility were observed across United States census regions. Imipenem-relebactam may provide a valuable therapeutic option for the treatment of ICU patients with LRTI caused by Gram-negative bacilli resistant to commonly used β-lactams, as it demonstrated potent in vitro activity against the majority of tested β-lactam-nonsusceptible and MDR Gram-negative bacilli from ICU patients with LRTIs in United States hospitals.
- | imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
Journal: Activity of imipenem/relebactam against carbapenemase-producing Enterobacteriaceae with high colistin resistance. (Pubmed Central) - Sep 19, 2020
Imipenem-relebactam may provide a valuable therapeutic option for the treatment of ICU patients with LRTI caused by Gram-negative bacilli resistant to commonly used β-lactams, as it demonstrated potent in vitro activity against the majority of tested β-lactam-nonsusceptible and MDR Gram-negative bacilli from ICU patients with LRTIs in United States hospitals. Imipenem/relebactam was the most potent agent tested against CPE in this study and may be a useful addition to the antimicrobial armamentarium to treat infections caused by these pathogens.
- [VIRTUAL] Meta-analysis of Randomized Control Trials Evaluating New Beta-Lactamase Combination Antibiotics () - Aug 14, 2020 - Abstract #IDWeek2020IDWEEK_1702;
Although older therapies had slightly higher microbiologic clearance, pooled clinical success rates for C/A, C/T, M/V, and I/R were non-inferior to older therapies, including in studies focused on patients with MDR infections. Additional studies are needed to further evaluate these drugs’ effectiveness for treatment of MDR infections.
- [VIRTUAL] In-Vitro Activity of Cefiderocol, Imipenem/Relebactam, & Ceftazidime/Avibactam in Ceftolozane/Tazobactam Resistant Strains of Multidrug Resistant Pseudomonas aeruginosa () - Aug 14, 2020 - Abstract #IDWeek2020IDWEEK_1643;
FDC also demonstrated activity against all 6 MDR P. aeruginosa carrying blaVIM gene. FDC is a strong option to consider on MDR P. aeruginosa strains based on a resistance testing algorithm and a cost/effective protocol.
- Zerbaxa (ceftolozane /tazobactam) / Merck (MSD), imipenem/relebactam / Merck (MSD)
[VIRTUAL] Frequency of Carbapenem-resistant Pseudomonas aeruginosa Among Respiratory Pathogens Impacts First-Line Beta-Lactam Susceptibility: Potential Role for Ceftolozane/Tazobactam (C/T) and/or Imipenem/Relebactam (I/R) () - Aug 14, 2020 - Abstract #IDWeek2020IDWEEK_1407;
Assessing CRPA frequency may be useful for identifying inflection points in which novel agents could be considered. In settings where CRPA frequency exceeded 20%, additional testing or early switch to C/T or I/R may be warranted.
- imipenem/relebactam / Merck (MSD)
[VIRTUAL] Frequency of carbapenemase-encoding genes among Imipenem-Resistant Gram-negative Bacilli isolated from Latin America: Is there a Role for Imipenem/Relebactam? Results from SMART 2017-2018 () - Aug 14, 2020 - Abstract #IDWeek2020IDWEEK_1406;
Important local variations were observed for some CEG variants detected only in specific countries. IMI/REL showed relevant in vitro activity against IMI-resistant ENT and MBL-negative PSA; and seems to be an important option for treatment of infections in LATAM.
- imipenem/relebactam / Merck (MSD)
[VIRTUAL] Epidemiology and Susceptibility to Imipenem/Relebactam of Gram-Negative Pathogens from Patients with Lower Respiratory Tract Infections – SMART United States 2017-2018 () - Aug 14, 2020 - Abstract #IDWeek2020IDWEEK_1288;
IMI/REL showed activity >90% against both Enterobacterales and Psa from both ward types. These in vitro data suggest that IMI/REL could provide an important treatment option for patients with LRTI in the US, including those in ICUs.
- meropenem / Generic mfg., Daewon Pharmaceutical
[VIRTUAL] Empiric Antibiotic Susceptibility Using a Traditional vs. Syndromic Antibiogram-Implications for Antimicrobial Stewardship Programs () - Aug 14, 2020 - Abstract #IDWeek2020IDWEEK_1276;
Our analysis demonstrated that susceptibilities were lower for first-line agents when stratified by ICU and P. aeruginosa. ASPs should consider syndromic antibiograms based on source and patient location to optimize empiric antibiotic therapy recommendations.
- imipenem/relebactam / Merck (MSD)
[VIRTUAL] Activity of Imipenem/Relebactam Against Clinical Isolates of P. aeruginosa and K. pneumoniae Collected in Asia/Pacific Countries – SMART 2016-2018 () - Aug 14, 2020 - Abstract #IDWeek2020IDWEEK_842;
IMI/REL was active against 91% of K. pneumoniae and 89% of P. aeruginosa isolates collected in Asia/Pacific overall, with higher activity in countries with lower MBL-positive rates. IMI/REL promises to be an important treatment option for IMI-nonsusceptible MBL-negative isolates, including KPC-producing K. pneumoniae.
- imipenem/relebactam / Merck (MSD)
[VIRTUAL] In Vitro Activity of Imipenem/Relebactam against Gram-Negative Pathogens from Patients with Bloodstream Infections in the United States and Canada – SMART 2018 () - Aug 14, 2020 - Abstract #IDWeek2020IDWEEK_749;
Multidrug-resistance (MDR) was defined as resistance to ≥3 of the following sentinel drugs: amikacin, aztreonam, cefepime, ceftazidime (NME only), ciprofloxacin, colistin, imipenem, and piperacillin/tazobactam...Susceptibility to IMI/REL and comparators of selected species and subsets of resistant phenotypes is shown in the table.IMI/REL was active against 99.8% of NME isolates; only meropenem, ceftazidime/avibactam, and amikacin showed comparable activity... In the US and Canada, IMI/REL could provide an important treatment option for patients with BSI caused by resistant gram-negative organisms.
- imipenem/relebactam / Merck (MSD)
[VIRTUAL] In Vitro Activity of Imipenem/Relebactam against Klebsiella pneumoniae and Pseudomonas aeruginosa from Patients in ICUs in the Asia/Pacific region – SMART 2015-2018 () - Aug 14, 2020 - Abstract #IDWeek2020IDWEEK_748;
IMI/REL was active against 92% of KP and 88% of PA from ICU patients in Asia/Pacific overall, with higher activity in countries with lower prevalence of MBL or OXA-48-like carbapenemases. IMI/REL provides a potential treatment option for ICU patients in Asia/Pacific with infections caused by KP and PA.
- | imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
Journal: Activity of imipenem/relebactam against MDR Pseudomonas aeruginosa in Europe: SMART 2015-17. (Pubmed Central) - Aug 13, 2020
IMI/REL provides a potential treatment option for ICU patients in Asia/Pacific with infections caused by KP and PA. Relebactam restored in vitro susceptibility to imipenem for most imipenem-non-susceptible and MDR clinical isolates of P. aeruginosa from European patients.
- | imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
Journal: Potentiation of imipenem by relebactam for Pseudomonas aeruginosa from bacteraemia and respiratory infections. (Pubmed Central) - Aug 12, 2020
Imipenem MICs were reduced to the current breakpoint, or lower, except for MBL producers. Potentiation was not compromised by derepression of AmpC or up-regulation of efflux.
- | imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
Preclinical, Journal: Antibacterial effect of imipenem/relebactam on aerobic Gram-negative bacilli: in vitro simulations of 7 or 14 day human exposures. (Pubmed Central) - Aug 12, 2020
Against P. aeruginosa, the initial bacterial burden was also rapidly reduced, but there was subsequent regrowth, especially after 7 days of exposure. Addition of amikacin increased the clearance of P. aeruginosa and prevented emergence of resistance.
- | relebactam (MK-7655) / Merck (MSD)
Journal: Imipenem/cilastatin sodium/relebactam fixed combination to treat urinary infections and complicated intra-abdominal bacterial infections. (Pubmed Central) - Jul 30, 2020
The combination (Recarbrio) has been designated as a qualified infectious disease product (QIDP) and obtained FDA approval in 2019 for the treatment of cUTI and cIAI caused by susceptible Gram-negative microorganisms in adult patients with limited or no alternative treatment options. The product was also approved by the European Medicines Agency (EMA) in 2020 for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.
- || imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
Clinical, PK/PD data, Journal: Population Pharmacokinetic Analysis for Imipenem-Relebactam in Healthy Volunteers and Patients With Bacterial Infections. (Pubmed Central) - Jul 29, 2020
Simulations were used to calculate probability of joint target attainment (ratio of free drug area under the curve from 0-24 hours to minimum inhibitory concentration [fAUC/MIC] for relebactam and percentage of time the free drug concentration exceeded the MIC [%fT>MIC] for imipenem) for the proposed imipenem/relebactam dose of 500/250 mg, with adjustments for patients with renal impairment, administered as a 30-minute intravenous infusion four times daily. These dosing regimens provide sufficient antibacterial coverage (MIC≤4 μg/mL) for all renal groups.
- | meropenem / Generic mfg., Daewon Pharmaceutical, relebactam (MK-7655) / Merck (MSD)
Journal: Carbapenem Non-susceptible Pseudomonas aeruginosa from Intensive Care Units in the United States: A Potential Role for New β-lactam Combination Agents. (Pubmed Central) - Jul 25, 2020
In these U.S. hospital ICUs, carbapenem-NS P. aeruginosa was frequently observed from respiratory sources. Novel β-lactam combination agents appear to retain active in vitro susceptibility profiles against these isolates and may play a role in treatment of infections caused by carbapenem-NS P. aeruginosa.
- | imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
Journal: Activity of imipenem-relebactam and comparator agents against genetically characterized isolates of carbapenem-resistant Enterobacteriaceae. (Pubmed Central) - Jul 19, 2020
Ninety-five percent of CRE bloodstream isolates were susceptible to imipenem-relebactam. In contrast to their comparable activity against KPC-producing CRE, ceftazidime-avibactam was more active in vitro against OXA-48-like CRE than imipenem-relebactam (90% susceptible vs. 15% susceptible).
- | imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
Preclinical, Journal, Combination therapy: In vitro Activity of Imipenem-Relebactam Alone or in Combination with Amikacin or Colistin against Pseudomonas aeruginosa. (Pubmed Central) - Jul 7, 2020
Against these 10 P. aeruginosa isolates, imipenem-relebactam combined with either amikacin or colistin resulted in synergistic activity against the majority of strains. Further studies evaluating combination therapy with imipenem-relebactam is warranted.
- | imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD), amoxicillin / Generic mfg.
Journal, Combination therapy: Effect of Amoxicillin in combination with Imipenem-Relebactam against Mycobacterium abscessus. (Pubmed Central) - May 28, 2020
Furthermore, we reverse the susceptibility by overexpressing Bla in M. abscessus, demonstrating relebactam-Bla target engagement. Finally, we highlight the in vitro efficacy of this combination against a panel of M. abscessus clinical isolates, revealing the therapeutic potential of the amoxicillin-imipenem-relebactam combination.
- imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
[VIRTUAL] Activity of imipenem-relebactam against a genetically diverse collection of carbapenemase-producing and non- producing carbapenem-resistant Enterobacteriaceae () - May 22, 2020 - Abstract #ECCMID2020ECCMID_5802;
This study highlights the diversity of resistance mechanisms underlying CRE in South Texas with almost 40% not harboring a carbapenemase. IMI-REL was highly effective against CRE including isolates producing carbapenmases with porin mutations, as well as all those that were also polymyxin-resistant.
- | imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
Preclinical, Journal, Combination therapy: Erratum for Asempa et al., "In Vitro Activity of Imipenem-Relebactam Alone or in Combination with Amikacin or Colistin against Pseudomonas aeruginosa". (Pubmed Central) - Apr 23, 2020
IMI-REL was highly effective against CRE including isolates producing carbapenmases with porin mutations, as well as all those that were also polymyxin-resistant. No abstract available
- | imipenem/relebactam / Merck (MSD)
Enrollment open: Imipenem-Relebactam Pharmacokinetics in Augmented Renal Clearance (clinicaltrials.gov) - Apr 20, 2020
P1, N=12, Recruiting, Sponsor: Hartford Hospital
No abstract available Not yet recruiting --> Recruiting
- [VIRTUAL] Comparative in vitro activity of ceftolozane/tazobactam, ceftazidime/avibactam, meropenem/vaborbactam, and imipenem/relebactam against susceptible and resistant Pseudomonas aeruginosa ([VIRTUAL]) - Feb 4, 2020 - Abstract #ECCMID2020ECCMID_5350;
- [VIRTUAL] Activity of imipenem-relebactam and meropenem-vaborbactam against ceftazidime-avibactam-resistant Klebsiella pneumoniae isolates producing KPC carbapenemases ([VIRTUAL]) - Feb 4, 2020 - Abstract #ECCMID2020ECCMID_5346;
- imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
[VIRTUAL] Retrospective analysis of the in vitro activity of imipenem/relebactam against KPC-encoding Enterobacterales ([VIRTUAL]) - Feb 4, 2020 - Abstract #ECCMID2020ECCMID_5341;
- imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
[VIRTUAL] Activity of imipenem-relebactam against a genetically diverse collection of carbapenemase-producing and non-producing carbapenem-resistant Enterobacteriaceae ([VIRTUAL]) - Feb 4, 2020 - Abstract #ECCMID2020ECCMID_5340;
- imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
[VIRTUAL] Activity of imipenem-relebactam against Enterobacterales and Pseudomonas aeruginosa isolates collected in Latin America and Brazil from 2017-2018: results from the Study for Monitoring Antimicrobial Resistance Trends (SMART) ([VIRTUAL]) - Feb 4, 2020 - Abstract #ECCMID2020ECCMID_5339;
- imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
[VIRTUAL] In vitro activity of imipenem/relebactam against non-Morganellaceae Enterobacterales, Pseudomonas aeruginosa and Acinetobacter baumannii isolates from patients with respiratory tract infections in the United States: SMART 2016-2018 ([VIRTUAL]) - Feb 4, 2020 - Abstract #ECCMID2020ECCMID_5336;
- imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
[VIRTUAL] In vitro activity of imipenem/relebactam against Klebsiella pneumoniae and Pseudomonas aeruginosa isolates from patients with respiratory tract infections in the Asia/Pacific region: SMART 2015-2018 ([VIRTUAL]) - Feb 4, 2020 - Abstract #ECCMID2020ECCMID_5335;
- imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
[VIRTUAL] In vitro activity of imipenem/relebactam against Klebsiella pneumoniae and Pseudomonas aeruginosa isolates from Patients in intensive care unit and non-intensive care unit wards in the Philippines: SMART 2016-2018 ([VIRTUAL]) - Feb 4, 2020 - Abstract #ECCMID2020ECCMID_5334;
- imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
[VIRTUAL] In vitro activity of imipenem/relebactam against Gram-negative organisms collected from patients in Colombia: SMART 2015-2018 ([VIRTUAL]) - Feb 4, 2020 - Abstract #ECCMID2020ECCMID_5333;
- imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
[VIRTUAL] In vitro activity of imipenem/relebactam against Gram-negative organisms collected globally from patients with different infection types: SMART 2018 ([VIRTUAL]) - Feb 4, 2020 - Abstract #ECCMID2020ECCMID_5332;
- imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
[VIRTUAL] In vitro activity of imipenem/relebactam against Pseudomonas aeruginosa isolates collected from patients in Europe: SMART 2018 ([VIRTUAL]) - Feb 4, 2020 - Abstract #ECCMID2020ECCMID_5330;
- imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
[VIRTUAL] Activity of imipenem/relebactam against non-Morganellaceae Enterobacterales and Pseudomonas aeruginosa Isolates from 6 countries in western Europe: SMART 2016-2018 ([VIRTUAL]) - Feb 4, 2020 - Abstract #ECCMID2020ECCMID_5329;
- imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
[VIRTUAL] Imipenem/relebactam pharmacokinetic/pharmacodynamic analyses from an in vivo neutropenic mouse delayed lung infection model ([VIRTUAL]) - Feb 4, 2020 - Abstract #ECCMID2020ECCMID_5199;
- imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
[VIRTUAL] Imipenem/relebactam pharmacokinetic/pharmacodynamic analyses from an in vivo neutropenic murine thigh infection model ([VIRTUAL]) - Feb 4, 2020 - Abstract #ECCMID2020ECCMID_5198;
- aztreonam / Generic mfg., imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
[VIRTUAL] Activity of aztreonam in combination with imipenem-relebactam against serine and metallo-β-lactamase-producing Enterobacteriaceae ([VIRTUAL]) - Feb 4, 2020 - Abstract #ECCMID2020ECCMID_4730;
- imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
[VIRTUAL] In vitro activity of imipenem/relebactam among Gram-negative clinical isolates in two Spanish tertiary hospitals ([VIRTUAL]) - Feb 4, 2020 - Abstract #ECCMID2020ECCMID_4728;
- aztreonam / Generic mfg., imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
[VIRTUAL] In vitro activity of imipenem-relebactam plus aztreonam against metallo-β-lactamase producing Pseudomonas aeruginosa ([VIRTUAL]) - Feb 4, 2020 - Abstract #ECCMID2020ECCMID_3954;
- [VIRTUAL] Baseline resistance to ceftazidime-avibactam and aztreonam-avibactam in carbapenemase-producing Enterobacterales from Argentina mediated by the co-expression of PER ESBL: role of imipenem-relebactam and aztreonam-relebactam as therapeutic alternatives ([VIRTUAL]) - Feb 4, 2020 - Abstract #ECCMID2020ECCMID_3393;
- imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
[VIRTUAL] ETEST Imipenem-relebactam for antimicrobial susceptibility testing of Enterobacteriaceae and Pseudomonas aeruginosa: performance results from a multi-centre study ([VIRTUAL]) - Feb 4, 2020 - Abstract #ECCMID2020ECCMID_1833;
- imipenem/relebactam / Merck (MSD), relebactam (MK-7655) / Merck (MSD)
[VIRTUAL] In vitro dynamics and mechanisms of resistance development to imipenem and imipenem/relebactam in Pseudomonas aeruginosa ([VIRTUAL]) - Feb 4, 2020 - Abstract #ECCMID2020ECCMID_1558;
- | Zerbaxa (ceftolozane /tazobactam) / Merck (MSD), imipenem/relebactam / Merck (MSD)
New trial: ACTHEON: In Vitro Activity of Ceftolozane/Tazobactam and Imipenem/Relebactam in Clinical Isolates of Pseudomonas Aeruginosa and Enterobacterales Collected From Hematology and Oncology Patients (clinicaltrials.gov) - Dec 12, 2019
P, N=1005, Recruiting, Sponsor: Emilio Bouza
- | imipenem/relebactam / Merck (MSD)
New P1 trial: Imipenem-Relebactam Pharmacokinetics in Augmented Renal Clearance (clinicaltrials.gov) - Nov 11, 2019
P1, N=12, Not yet recruiting, Sponsor: Hartford Hospital