Ceftolozane/tazobactam for pulmonary exacerbation in a 63-year-old cystic fibrosis patient with renal insufficiency and an elevated MIC to Pseudomonas aeruginosa

Romano, Meredith Tate; Premraj, Sasha; Bray, John M.; Murillo, Luis C.

doi:10.1016/j.idcr.2020.e00830

Cited by 17 publications

(17 citation statements)

References 19 publications

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“…Of the 83 studies included in the SLR, 61 were published as peer-reviewed publications [ 18 – 78 ], and 22 were conference proceedings (availability as abstracts or posters) [ 79 – 100 ]. Including studies that recruited patients from multiple countries, the most common study locations were the US (N = 50), [ 21 , 22 , 24 , 27 – 29 , 33 , 34 , 39 – 41 , 43 – 45 , 50 , 51 , 54 , 56 , 57 , 59 , 61 , 62 , 68 – 71 , 73 – 77 , 79 – 85 , 87 – 92 , 94 , 95 , 97 – 100 ] Spain (N = 15) [ 26 , 28 , 30 – 32 , 35 – 37 , 42 , 47 , 49 , 58 , 66 , 79 , 96 ], and Italy (N = 13) [ 18 , 20 , 23 , 25 , 48 , 52 , 53 , 55 , 64 , 67 , 72 , 79 , 86 ]. A variety of study designs were captured: 27 were non-comparative retrospective studies [ 18 , 19 , 22 ,…”

Section: Resultsmentioning

confidence: 99%

Real-world use of ceftolozane/tazobactam: a systematic literature review

Puzniak

Dillon

Palmer

et al. 2021

Antimicrob Resist Infect Control

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Background Antibacterial-resistant gram-negative infections are a serious risk to global public health. Resistant Enterobacterales and Pseudomonas aeruginosa are highly prevalent, particularly in healthcare settings, and there are limited effective treatment options. Patients with infections caused by resistant pathogens have considerably worse outcomes, and incur significantly higher costs, relative to patients with susceptible infections. Ceftolozane/tazobactam (C/T) has established efficacy in clinical trials. This review aimed to collate data on C/T use in clinical practice. Methods This systematic literature review searched online biomedical databases for real-world studies of C/T for gram-negative infections up to June 2020. Relevant study, patient, and treatment characteristics, microbiology, and efficacy outcomes were captured. Results There were 83 studies comprising 3,701 patients were identified. The most common infections were respiratory infections (52.9% of reported infections), urinary tract infections (UTIs; 14.9%), and intra-abdominal infections (IAIs; 10.1%). Most patients included were seriously ill and had multiple comorbidities. The majority of patients had infections caused by P.aeruginosa (90.7%), of which 86.0% were antimicrobial-resistant. C/T was used as both a 1.5 g q8h and 3 g q8h dose, for a median duration of 7–56 days (varying between studies). Outcome rates were comparable between studies: clinical success rates ranged from 45.7 to 100.0%, with 27 studies (69%) reporting clinical success rates of > 70%; microbiological success rates ranged from 31 to 100%, with 14 studies (74%) reporting microbiological success rates of > 70%. Mortality rates ranged from 0 to 50%, with 31 studies (69%) reporting mortality rates of ≤ 20%. In comparative studies, C/T was as effective as aminoglycoside- or polymyxin-based regimens, and in some instances, significantly more effective. Conclusions The studies identified in this review demonstrate that C/T is effective in clinical practice, despite the diverse group of seriously ill patients, different levels of resistance of the pathogens treated, and varying dosing regimens used. Furthermore, comparative studies suggest that C/T offers a successful alternative to standard of care (SoC).

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Section: Resultsmentioning

confidence: 99%

Real-world use of ceftolozane/tazobactam: a systematic literature review

Puzniak

Dillon

Palmer

et al. 2021

Antimicrob Resist Infect Control

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“…While potentially elevated MICs may be observed with the ETEST method, these values may also assist in optimizing antibiotic dosing regimens. Several case reports have reported success in treating CF acute pulmonary exacerbation caused by MDR P. aeruginosa using high-dose, pharmacodynamically optimized regimens based on ETEST derived MICs and therapeutic drug monitoring [ 19 , 20 , 30 ].…”

Section: Discussionmentioning

confidence: 99%

Contemporary analysis of ETEST for antibiotic susceptibility and minimum inhibitory concentration agreement against Pseudomonas aeruginosa from patients with cystic fibrosis

Lasko

Huse

Nicolau

et al. 2021

Ann Clin Microbiol Antimicrob

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Objectives Cystic fibrosis (CF) acute pulmonary exacerbations are often caused by Pseudomonas aeruginosa, including multi-drug resistant strains. Optimal antibiotic therapy is required to return lung function and should be guided by in vitro susceptibility results. There are sparse data describing ETEST performance for CF isolates using contemporary isolates, methods and interpretation, as well as novel antibiotics, such as ceftazidime–avibactam and ceftolozane–tazobactam. Methods Pseudomonas aeruginosa (n = 105) isolated during pulmonary exacerbation from patients with CF were acquired from 3 US hospitals. Minimum inhibitory concentrations (MICs) were assessed by reference broth microdilution (BMD) and ETEST for aztreonam, cefepime, ceftazidime, ceftazidime–avibactam, ceftolozane–tazobactam, ciprofloxacin, levofloxacin, meropenem, piperacillin–tazobactam, and tobramycin. Broth microdilution was conducted in concordance with the Clinical and Laboratory Standards Institute M100. ETEST methodology reflected package insert recommendations. Performance of ETEST strips was evaluated using the Food and Drug Administration (FDA) and Susceptibility Testing Manufacturers Association (STMA) guidance. Results Of the 105 P. aeruginosa included, 46% had a mucoid phenotype. ETEST MICs typically read 0–1 dilution higher than BMD for all drugs. Categorical agreement and essential agreement ranged from 64 to 93% and 63 to 86%, respectively. The majority of observed errors were minor. A single very major error occurred with ceftazidime (4.2%). For ceftazidime–vibactam, 2 very major errors were observed and both were within essential agreement. Major errors occurred for aztreonam (3.3%), cefepime (9.4%), ceftazidime–avibactam (5.3%, adjusted 2.1%), ceftolozane–tazobactam (1%), meropenem (3.3%), piperacillin–tazobactam (2.9%), and tobramycin (1.5%). Conclusions ETEST methods performed conservatively for most antibiotics against this challenging collection of P. aeruginosa from patients with CF.

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“…Every included study reported outcomes for respiratory patients: 29 reported clinical outcomes, 15-25,27−30,32-34,36−46 13 reported microbiological outcomes, 15-17, 24,25,29, 32-35,38,42, 44 and 26 reported mortality outcomes. [15][16][17]20,21,[24][25][26][27][28][29][31][32][33][34][36][37][38][39][40][41][42][43][44][45]47 Excluding single patient case reports, 17 studies (including 494 patients) reported clinical success rates of 51.4 22 -100.0%, 16,25,30,44,46 with 10 studies (55.6%) reporting success rates of > 70%. 16,18,19,23,25,30,42,44−46 In larger studies (> 30 patients; seven studies), 18,19,22,24,36,43,45 clinical success rates ranged from 51.4 22 -78.3%.…”

Section: Overall Outcomesmentioning

confidence: 99%

“…25,44 Outcomes were consistent in studies including one patient (14 case reports and one case series with a single respiratory patient). 15,17,21,26,29,[32][33][34][35][37][38][39][40][41]47 Clinical success was reported in 11 of 12 studies (91.7%), 15,17,21,29,32-34,37−41 microbiological success was reported in 7 of 8 studies (87.5%), 15,17,29,[32][33][34][35]38 30-day mortality in 0 of 5 studies (0.0%), [37][38][39][40][41] and unspeci ed-timeframe mortality in 2 of 9 studies (22.2%). 15,17,21,26,29,[32][33][34]47…”

Section: Overall Outcomesmentioning

confidence: 99%

Systematic Literature Review of Real-World Evidence of C Eftolozane/Tazobactam for the Treatment of Respiratory Infections

Puzniak

Dillon

Palmer³

et al. 2021

Preprint

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Background: Gram-negative nosocomial pneumonia (NP), including hospital-acquired bacterial pneumonia (HABP), ventilated HABP (vHABP), and ventilator-associated bacterial pneumonia (VABP), is a significant cause of morbidity and mortality. Common pathogens, including Enterobacterales and Pseudomonas aeruginosa are highly prevalent in healthcare settings and have few effective treatment options due to high rates of antibacterial resistance. Resistant pathogens are associated with significantly worse outcomes and higher costs, relative to patients with susceptible infections. Ceftolozane/tazobactam (C/T) has established efficacy in clinical trials of patients with NP. This review aimed to collate data on C/T use for HABP/vHABP/VABP infections in real-world clinical practice. Methods: This systematic literature review searched online biomedical databases for real-world studies of C/T for gram-negative respiratory tract infections (RTIs) up to June 2020. Relevant study, patient, and treatment characteristics, microbiology, and efficacy outcomes were captured.Results: Thirty-three studies comprising 658 patients were identified. Pneumonia was the most common infection C/T was used to treat (85%), with a smaller number of unspecified RTIs (9%) and tracheobronchitis (5%) reported. Data on severity of illness and comorbidity were inconsistently reported. The majority of patients had respiratory infections caused by P. aeruginosa (92.8%), of which 88.1% were multidrug-resistant (including extensively drug-resistant or pandrug-resistant). Examination of these studies demonstrated an increase in the percentage of patients receiving the recommended dose of C/T for respiratory infections (3 g q8h or renal impairment-adjusted) over time (36.8% of patients in 2017 to 71.5% in 2020). Clinical success rates ranged from 51.4–100%, with 10 studies (55.6% of studies reporting clinical success) reporting clinical success rates of >70%; microbiological success rates ranged from 57.0–100.0%, with three studies (60.0% of studies reporting microbiological success) reporting microbiological success rates of >70%. Thirty-day mortality ranged from 0.0–33.0%, with nine studies (90% of studies reporting mortality) reporting 30-day mortality of <30%. Conclusions: The studies identified in this review demonstrate that C/T shows similar outcomes as those seen in clinical trials, despite the higher frequency of multidrug-resistant pathogens, and comorbidities/conditions that may have been excluded from the trials.

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Ceftolozane/tazobactam for pulmonary exacerbation in a 63-year-old cystic fibrosis patient with renal insufficiency and an elevated MIC to Pseudomonas aeruginosa

Cited by 17 publications

References 19 publications

Real-world use of ceftolozane/tazobactam: a systematic literature review

Real-world use of ceftolozane/tazobactam: a systematic literature review

Contemporary analysis of ETEST for antibiotic susceptibility and minimum inhibitory concentration agreement against Pseudomonas aeruginosa from patients with cystic fibrosis

Systematic Literature Review of Real-World Evidence of C Eftolozane/Tazobactam for the Treatment of Respiratory Infections

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