Drug updated on 12/11/2024
Dosage Form | Injection (intravenous; 500 mg/ 10mL [50 mg/mL] in a single-dose vial containing plazomicin sulfate equivalent to 500 mg plazomicin free base) |
Drug Class | Aminoglycoside 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
- This summary is based on the review of one randomized controlled trial. [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% confidence interval (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 Title | Year | Source |
---|---|---|
Zemdri (plazomicin) Prescribing Information. | 2023 | Cipla USA, Inc., Warren, NJ |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
Once-Daily Plazomicin for Complicated Urinary Tract Infections | 388Subjects F: 53% M: 47% | 2019 | The New England Journal of Medicine |
Sex Distribution:
F:53%
M:47%
388Subjects
Year:
2019
Source:The New England Journal of Medicine