- |||||||||| Zavicefta (ceftazidime/avibactam) / Pfizer, AbbVie
Journal: Antimicrobial susceptibility testing of Enterobacteriaceae: determination of disk content and Kirby-Bauer breakpoint for ceftazidime/avibactam. (Pubmed Central) - Jul 31, 2020 Our results show that 30 μg/50 μg, 30 μg/25 μg, 30 μg/10 μg CAZ/AVI disk have significant statistical differences to determinate CAZ/AVI antibacterial activity, but for 30 μg/50 μg disk, there has a cross section between susceptible isolates (minimum 20.5 mm) and resistance isolates (maximum 21.5 mm). For 30 μg/25 μg disk, it is hard to distinguish the difference between susceptible isolates (minimum 19.7 mm) and resistance isolates (maximum 19.2 mm), so 30 μg/10 μg CAZ/AVI disk is more conducive to determinate antibacterial activity.
- |||||||||| Zavicefta (ceftazidime/avibactam) / Pfizer, AbbVie
Enrollment change, Trial completion date, Real-world evidence, Real-world: EZTEAM: Real-World Observational Study Of Zavicefta to Characterize Use Patterns (clinicaltrials.gov) - Jul 23, 2020 P=N/A, N=700, Recruiting, With in vivo validation, piperacillin-tazobactam-ceftazidime-avibactam may represent salvage therapy for individuals with CF and highly drug-resistant Bcc and Bgladioli infections. N=1030 --> 700 | Trial completion date: Mar 2022 --> Jun 2022
- |||||||||| Zerbaxa (ceftolozane /tazobactam) / Merck (MSD), meropenem / Generic mfg., Daewon Pharmaceutical, Zavicefta (ceftazidime/avibactam) / Pfizer, AbbVie
Journal, HEOR: Cost-effectiveness analysis comparing ceftazidime/avibactam (CAZ-AVI) as empirical treatment comparing to ceftolozane/tazobactam and to meropenem for complicated intra-abdominal infection (cIAI). (Pubmed Central) - Jul 19, 2020 P3 The incremental cost effectiveness ratio in the CAZ-AVI sequence was €4099 and €15,574 per QALY gained versus each comparator sequence, respectively, well below the willingness-to-pay threshold of €30,000 per QALY accepted in Italy. The model results demonstrated that CAZ-AVI plus metronidazole could be a cost-effective alternative when compared with other antibiotic treatment options, as it is expected to provide better clinical benefits in hospitalised patients with cIAI in Italy.
- |||||||||| Zavicefta (ceftazidime/avibactam) / Pfizer, AbbVie
Review, Journal: Ceftazidime/avibactam for specified infections. (Pubmed Central) - Jul 19, 2020 The model results demonstrated that CAZ-AVI plus metronidazole could be a cost-effective alternative when compared with other antibiotic treatment options, as it is expected to provide better clinical benefits in hospitalised patients with cIAI in Italy. No abstract available
- |||||||||| Zavicefta (ceftazidime/avibactam) / Pfizer, AbbVie
Clinical, PK/PD data, Review, Journal: Clinical Pharmacokinetics and Pharmacodynamics of Ceftazidime-Avibactam Combination: A Model-Informed Strategy for its Clinical Development. (Pubmed Central) - Jul 9, 2020 The clinical dosing regimen of 2/0.5 g ceftazidime/avibactam administered every 8 h as a 2-h intravenous infusion in patients with normal renal function, with dose adjustment in renal impairment, demonstrated statistical non-inferiority to carbapenem in phase III studies on the treatment of complicated intra-abdominal infection, complicated urinary tract infection, and nosocomial pneumonia, including ceftazidime non-susceptible Gram-negative pathogens. The success of the phase III studies validated the dose selection and exposure target that were associated with efficacy based on a model-informed approach.
- |||||||||| meropenem / Generic mfg., Daewon Pharmaceutical
Review, Journal: Choice of therapeutic interventions and outcomes for the treatment of infections caused by multidrug-resistant gram-negative pathogens: a systematic review. (Pubmed Central) - Jul 8, 2020 We did not find robust evidence for antibiotic treatment of any infection with MDR Gram-negative bacteria, including ESBL-producing Enterobacteriaceae, A. baumannii, and P. aeruginosa, that would lead to a firm recommendation for one specific antibiotic over another or for monotherapy over combination therapy. The choice of antibiotic treatment should be based on susceptibility testing balancing the expected clinical success rate against the risk of development of antibiotic resistance and the risk of severe side effects.
- |||||||||| Baxdela (delafloxacin) / Menarini, Melinta Therap, Vabomere (meropenem/vaborbactam) / Melinta Therap, Zavicefta (ceftazidime/avibactam) / Pfizer, AbbVie
Review, Journal: Estimating Renal Function in Drug Development: Time to Take the Fork in the Road. (Pubmed Central) - Jul 2, 2020 Finally, we suggest measuring GFR in phase 1 studies and employing the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation to integrate data across clinical trials. This will help to harmonize CKD staging, population pharmacokinetic analyses, and dosing by estimated renal function.
- |||||||||| Zavicefta (ceftazidime/avibactam) / Pfizer, AbbVie
Journal: Emergence of ceftazidime-avibactam-resistant Klebsiella pneumoniae during treatment, Finland, December 2018. (Pubmed Central) - Jul 2, 2020 CAZ-AVI resistance was observed 34 days after CAZ-AVI treatment in a trauma patient transferred from a hospital in Greece who had been colonised with bla-producing K. pneumoniae ST39, and later developed a bloodstream infection. The CAZ-AVI-resistant strain contained a novel 15 amino acid insertion in the KPC-2 protein causing structural changes proximal to the KPC-2 active site.
- |||||||||| Clinical, Journal: Treatment of Carbapenem-Resistant Enterobacteriaceae Infections in Children. (Pubmed Central) - Jul 2, 2020
A lack of pediatric-specific comparative effectiveness data, uncertain pediatric dosing regimens for several agents, and a relative lack of new antibiotics with pediatric indications approved by the US Food and Drug Administration (FDA) collectively present unique challenges for children. In this review, we provide a framework for antibiotic treatment of CRE infections in children, highlighting relevant microbiologic considerations and summarizing available data related to the evaluation of FDA-approved antibiotics (as of September 2019) with CRE activity, including carbapenems, ceftazidime-avibactam, meropenem-vaborbactam, imipenem/cilastatin-relebactam, polymyxins, tigecycline, eravacycline, and plazomicin.
- |||||||||| meropenem / Generic mfg., Daewon Pharmaceutical, Zavicefta (ceftazidime/avibactam) / Pfizer, AbbVie
Preclinical, Journal: Longitudinal analysis of the in vitro activity of ceftazidime-avibactam vs. Enterobacteriaceae, 2012-2016. (Pubmed Central) - Jun 29, 2020 In this review, we provide a framework for antibiotic treatment of CRE infections in children, highlighting relevant microbiologic considerations and summarizing available data related to the evaluation of FDA-approved antibiotics (as of September 2019) with CRE activity, including carbapenems, ceftazidime-avibactam, meropenem-vaborbactam, imipenem/cilastatin-relebactam, polymyxins, tigecycline, eravacycline, and plazomicin. Clinical isolates of Enterobacteriaceae, including ESBL-positive phenotypes, collected globally (excluding North America) from 2012 to 2016 were highly susceptible to ceftazidime-avibactam, suggesting it is a useful agent for serious infections caused by multidrug-resistant organisms belonging to the Enterobacteriaceae when therapeutic options are limited.
- |||||||||| ciprofloxacin / Generic mfg., meropenem / Generic mfg., Daewon Pharmaceutical, Zavicefta (ceftazidime/avibactam) / Pfizer, AbbVie
Detection of ceftazidime-avibactam resistance in Pseudomonas aeruginosa isolates () - Jun 29, 2020 - Abstract #ECFS2020ECFS_291; Colistin and tobramycin demonstrated the most activity in vitro against these isolates. Further work will include investigating mechanisms of CZA resistance.
- |||||||||| Zerbaxa (ceftolozane /tazobactam) / Merck (MSD), Vabomere (meropenem/vaborbactam) / Melinta Therap, Zavicefta (ceftazidime/avibactam) / Pfizer, AbbVie
Journal: Emerging antibiotic resistance: carbapenemase-producing enterobacteria. Bad new bugs, still no new drugs. (Pubmed Central) - Jun 28, 2020 Few limited options are available to treat infections due to Carbapenem Resistant Enterobacteria. Antimicrobial molecules with true novel mechanism of action are needed to win the fight against antimicrobial resistance.
- |||||||||| Review, Journal: Recommendation of Antimicrobial Dosing Optimization During Continuous Renal Replacement Therapy. (Pubmed Central) - Jun 19, 2020
Here, we reviewed the literatures involving in new progresses of antimicrobial dosages, and complied the updated empirical dosing strategies based on CRRT modalities and effluent flow rates. The following antimicrobial agents were included for review: flucloxacillin, piperacillin/tazobactam, ceftriaxone, ceftazidime/avibactam, cefepime, ceftolozane/tazobactam, sulbactam, meropenem, imipenem, panipenem, biapenem, ertapenem, doripenem, amikacin, ciprofloxacin, levofloxacin, moxifloxacin, clindamycin, azithromycin, tigecycline, polymyxin B, colistin, vancomycin, teicoplanin, linezolid, daptomycin, sulfamethoxazole/trimethoprim, fluconazole, voriconazole, posaconzole, caspofungin, micafungin, amphotericin B, acyclovir, ganciclovir, oseltamivir, and peramivir.
- |||||||||| Vabomere (meropenem/vaborbactam) / Melinta Therap, Zemdri (plazomicin) / Ionis, Achaogen, Zavicefta (ceftazidime/avibactam) / Pfizer, AbbVie
Clinical, P4 data, Review, Journal, Head-to-Head: Non-inferiority versus superiority trial design for new antibiotics in an era of high antimicrobial resistance: the case for post-marketing, adaptive randomised controlled trials. (Pubmed Central) - Jun 18, 2020 Using an example of the development process of ceftazidime-avibactam, we propose a strategy for a new research framework based on adaptive randomised clinical trials. The operational research strategy has the aim of assessing the efficacy of new antibiotics in special groups of patients, such as those infected with multidrug-resistant bacteria, who were not included in earlier phase studies, and for whom it is important to establish an appropriate standard of care.
- |||||||||| ciprofloxacin / Generic mfg.
Journal: Treatment of urinary tract infections in the era of antimicrobial resistance and new antimicrobial agents. (Pubmed Central) - Jun 18, 2020 Ceftazidime-avibactam, meropenem/vaborbactam, imipenem/cilastatin-relebactam, colistin, fosfomycin, aztreonam and ceftazidime-avibactam, aztreonam and amoxicillin-clavulanate, aminoglycosides including plazomicin, cefiderocol, tigecycline are treatment options for UTIs caused by carbapenem-resistant Enterobacteriales (CRE)...include fluoroquinolones, ceftazidime, cefepime, piperacillin-tazobactam, carbapenems including imipenem-cilastatin/relebactam, meropenem and fosfomycin, ceftolozane-tazobactam, ceftazidime-avibactam, aminoglycosides including plazomicin, aztreonam and ceftazidime-avibactam, cefiderocol, and colistin. It is important to use the new antimicrobials wisely for treatment of UTIs caused by MDR- organisms to avoid resistance development.
- |||||||||| Garamycin (gentamicin sulfate) / Generic mfg.
Clinical, Journal: Molecular and phenotypic characterization of clinical isolates belonging to a KPC-2-producing strain of ST15 Klebsiella pneumoniae from a Vietnamese pediatric hospital. (Pubmed Central) - Jun 18, 2020 Aside from the carbapenem resistance gene bla, which was carried by all isolates, prevalence of resistance genes to other antibiotics including aminoglycosides, macrolides, quinolones, fosfomycin and trimethoprim, was also high...Susceptibility was highest to ceftazidime/avibactam (96%), gentamicin (91%) and tigecycline (82%)...The diverse variety of antibiotic resistance genes and the high antibiotic resistance rates to last-resort antibiotics such as carbapenems and colistin, is indicative of a highly adaptable strain. This emphasizes the importance of implementation of infection controls measures, continued monitoring of antibiotic resistance and prudent use of antibiotics to prevent further selection of resistant strains and the emergence of pan-resistant clones.
- |||||||||| ceftaroline/avibactam (ceftaroline fosamil/ NXL104) / Pfizer, Teflaro (ceftaroline fosamil) / Sumitomo Dainippon, AstraZeneca, AbbVie, Zavicefta (ceftazidime/avibactam) / Pfizer, AbbVie
Preclinical, Journal: ERRATUM TO: In Vitro Activities of Ceftaroline/Avibactam, Ceftazidime/Avibactam, and Other Comparators Against Pathogens From Various Complicated Infections in China. (Pubmed Central) - Jun 17, 2020 This emphasizes the importance of implementation of infection controls measures, continued monitoring of antibiotic resistance and prudent use of antibiotics to prevent further selection of resistant strains and the emergence of pan-resistant clones. No abstract available
- |||||||||| Journal: New antibiotics: an overview (Pubmed Central) - Jun 8, 2020
Two new glycopeptides (oritavancin and dalbavancin) and a new oxazolidinone (tedizolid) are now registered for the treatment of acute skin and soft-tissue infections...Examples of these are ceftolozane-tazobactam, ceftazidime-avibactam and meropenem-vaborbactam...There has been a great increase in investment in the development of new antimicrobials. Also, regulatory agencies have accelerated their assessment of these new - and urgently needed - drugs.
- |||||||||| Zerbaxa (ceftolozane /tazobactam) / Merck (MSD), Arbelic (telavancin) / Cumberland, Zavicefta (ceftazidime/avibactam) / Pfizer, AbbVie
Journal: Renal Dosing of Antibiotics: Are We Jumping the Gun? (Pubmed Central) - May 29, 2020 Using a clinical database, we identify AKI on admission in a substantial proportion of patients with pneumonia (27.1%), intra-abdominal (19.5%), urinary tract (20.0%), or skin and skin structure infections (9.7%) that resolved by 48 hours in 57.2% of cases. We suggest that deferred renal dose reduction of wide therapeutic index antibiotics could improve outcomes in patients with infectious diseases.
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