Plazomicin

(Zemdri®)

Zemdri®

Drug updated on 10/29/2024

Dosage FormInjection (intravenous; 500 mg/ 10mL [50 mg/mL] in a single-dose vial containing plazomicin sulfate equivalent to 500 mg plazomicin free base)
Drug ClassAminoglycoside antibacterials
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI) including pyelonephritis.

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Summary
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  • This summary is based on the review of one randomized controlled trial(s). [1]
  • Primary Efficacy End Points: Plazomicin achieved a composite cure rate of 88.0% (168/191) at day 5, compared to 91.4% (180/197) for meropenem, with a difference of -3.4 percentage points (95% CI: -10.0 to 3.1). At the test-of-cure visit, plazomicin had an efficacy of 81.7% (156/191), significantly higher than meropenem’s 70.1% (138/197), resulting in a difference of 11.6 percentage points (95% CI: 2.7 to 20.3).
  • Microbiologic Eradication Rates: Plazomicin demonstrated superior microbiologic eradication rates at the test-of-cure visit, with 78.8% eradication of Enterobacteriaceae not susceptible to aminoglycosides compared to 68.6% for meropenem, and 82.4% versus 75.0% for Enterobacteriaceae producing extended-spectrum beta-lactamases.
  • Recurrence and Relapse Rates: At late follow-up, microbiologic recurrence rates were lower for plazomicin (3.7%) than for meropenem (8.1%), and clinical relapse rates were also lower, with 1.6% for plazomicin compared to 7.1% for meropenem.
  • Increases in serum creatinine levels of 0.5 mg or more per deciliter were observed in 7.0% of patients receiving plazomicin compared to 4.0% of patients receiving meropenem.
  • The study included patients with complicated urinary tract infections (UTIs), including acute pyelonephritis, but did not provide further breakdown of effectiveness or safety outcomes by specific subgroups such as age, gender, or comorbid conditions.

Product Monograph / Prescribing Information

Document TitleYearSource
Zemdri (plazomicin) Prescribing Information.2023Cipla USA, Inc., Warren, NJ

Randomized Controlled Trials

Document TitleSex DistributionYearSource
Once-Daily Plazomicin for Complicated Urinary Tract Infections
388Subjects
F: 53%
M: 47%
2019The New England Journal of Medicine

Sex Distribution:

F:53%
M:47%
388Subjects

Year:

2019

Source:The New England Journal of Medicine

Clinical Practice Guidelines