Improved Outcomes with Plazomicin (PLZ) Compared with Colistin (CST) in Patients with Bloodstream Infections (BSI) Caused by Carbapenem-resistant Enterobacteriaceae (CRE): Results from the CARE Study

McKinnell, James A.; Connolly, Lynn; Pushkin, Richard; Jubb, Adrian M.; O’Keeffe, Bridget; Serio, Alisa W.; Smith, A. Hayes; Gall, Jonathan; Riddle, Valerie; Krause, Kevin M.; Pogue, Jason M.

doi:10.1093/ofid/ofx163.1383

Cited by 32 publications

(30 citation statements)

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“…The efficacy of plazomicin for the treatment of VAP is unknown, and the ELF:serum AUC ratio was ~13% [80]. Of note, plazomicin’s renal toxicity profile appeared favorable compared with colistin [83, 84]. …”

Section: Contemporary Treatment Strategies For Gram-negative Vapmentioning

confidence: 99%

Resistance Trends and Treatment Options in Gram-Negative Ventilator-Associated Pneumonia

Rhodes

Cruce

O’Donnell

et al. 2018

Curr Infect Dis Rep

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Rapid identification technologies and phenotypic methods, new therapeutic strategies, and novel treatment paradigms have evolved in an attempt to improve treatment outcomes for VAP; however, clinical data supporting alternative treatment strategies and adjunctive therapies remain sparse. Importantly, new classes of antimicrobials, novel virulence factor inhibitors, and beta-lactam/beta-lactamase inhibitor combinations are currently in development. Conscientious stewardship of new and emerging therapeutic agents will be needed to ensure they remain effective well into the future.

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Section: Contemporary Treatment Strategies For Gram-negative Vapmentioning

confidence: 99%

Resistance Trends and Treatment Options in Gram-Negative Ventilator-Associated Pneumonia

Rhodes

Cruce

O’Donnell

et al. 2018

Curr Infect Dis Rep

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“…The efficacy and safety of plazomicin were evaluated in a single phase II study and phase III study for cUTIs in adult patients . Plazomicin was also evaluated in one phase III study for serious infections caused by CRE in adult patients . Table summarizes these clinical trials …”

Section: Clinical Efficacymentioning

confidence: 99%

“…In the clinically evaluable patients, 4 had cUTI/AP, 9 had HABP/VABP, and 14 had BSI . The investigators reported results for plazomicin in the subgroup with BSI only; the rate of ACM at day 28 or SDRCs was 35.7% (5/14), with most events driven by SDRCs (28.6% [4/14]) . The higher rate of SDRCs could be associated with three patients who had persistent CRE bacteremia associated with IV catheters that subsequently resolved .…”

Section: Clinical Efficacymentioning

confidence: 99%

“…Investigators then conducted a subgroup analysis on all patients enrolled in both cohorts of the study who had a confirmed CRE‐associated BSI (29 in cohort 1; 14 in cohort 2) . Patients treated with plazomicin had a lower rate of ACM or SDRC (14.3% [2/14] vs 53.3% [8/15], −39, 90% CI −65.5 to 9.4) and ACM alone (7.1% [1/14] vs 40% [6/15] −32.9, 90% CI −60.1 to 4.0) compared with those with a colistin‐based treatment (Table ).…”

Section: Clinical Efficacymentioning

confidence: 99%

“…27,60,61 Plazomicin was also evaluated in one phase III study for serious infections caused by CRE in adult patients. 62,63 Table 4 summarizes these clinical trials. [60][61][62] Complicated Urinary Tract Infections…”

Section: Clinical Efficacymentioning

confidence: 99%

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Plazomicin: A Next‐Generation Aminoglycoside

et al. 2019

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Plazomicin is a novel aminoglycoside antibiotic that binds to the bacterial 30S ribosomal subunit, thus inhibiting protein synthesis in a concentration‐dependent manner. Plazomicin displays a broad spectrum of activity against aerobic gram‐negative bacteria including extended‐spectrum β‐lactamase–producing Enterobacteriaceae, carbapenem‐resistant Enterobacteriaceae, and organisms with aminoglycoside‐modifying enzymes. In a large phase III clinical trial, plazomicin was shown to be noninferior to meropenem in the treatment of complicated urinary tract infections (cUTIs) with respect to the coprimary efficacy end points of the microbiologically modified intent‐to‐treat composite cure rate at day 5 (plazomicin 88% [168/191 subjects] vs meropenem 91.4% [180/197]) and at the test‐of‐cure visit (plazomicin 81.7% [156/191] vs meropenem 70.1% [138/197]). In a small phase III clinical trial, plazomicin was shown to be effective in the treatment of infections caused by carbapenem‐resistant Enterobacteriaceae. It was associated with a lower all‐cause mortality or significant disease‐related complication rate (23.5% [4/17]) compared with colistin (50% [10/20]). The most common adverse reactions associated with plazomicin are decreased renal function, diarrhea, hypertension, headache, nausea, vomiting, and hypotension. As with other aminoglycosides, plazomicin may cause neuromuscular blockade, ototoxicity, and fetal harm in pregnant women. Due to limited efficacy and safety data, plazomicin is indicated for the treatment of cUTIs in adults with limited or no alternative treatment options, using a dosage regimen of 15 mg/kg intravenously every 24 hours for 4–7 days. Dosage reductions and therapeutic drug monitoring are warranted in patients with moderate or severe renal impairment. Plazomicin is not recommended in patients with severe renal impairment including those receiving renal replacement therapy. With the approval of plazomicin, clinicians now have an additional option for the treatment of adults with cUTIs, particularly those caused by multidrug‐resistant gram‐negative rods.

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Overcoming Antibiotic Resistance: New Perspectives

Bassetti

Righi

2020

Human Perspectives in Health Sciences and Technology

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Improved Outcomes with Plazomicin (PLZ) Compared with Colistin (CST) in Patients with Bloodstream Infections (BSI) Caused by Carbapenem-resistant Enterobacteriaceae (CRE): Results from the CARE Study

Cited by 32 publications

References 0 publications

Resistance Trends and Treatment Options in Gram-Negative Ventilator-Associated Pneumonia

Resistance Trends and Treatment Options in Gram-Negative Ventilator-Associated Pneumonia

Plazomicin: A Next‐Generation Aminoglycoside

Overcoming Antibiotic Resistance: New Perspectives

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