Drug updated on 3/28/2024
| Dosage Form | Injection (intravenous; 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
- For the treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI) including pyelonephritis.
Summary
- Plazomicin (Zemdri) is indicated for the treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI), including pyelonephritis.
- Two randomized controlled trials were reviewed, providing evidence on the efficacy and safety profile of plazomicin in treating cUTIs.
- The first trial demonstrated that once-daily plazomicin was noninferior to meropenem in treating complicated UTIs and acute pyelonephritis caused by Enterobacteriaceae, including multidrug-resistant strains.
- In this study, composite cure at day 5 was observed in 88% of patients treated with plazomicin compared to 91.4% treated with meropenem; however, a higher percentage of patients had microbiologic eradication at test-of-cure visit when using plazomicin than those using meropenem (81.7% vs 70.1%, respectively).
- The second trial showed similar results where both doses tested for Plazomicin resulted in high rates (>85%) microbiological eradication among evaluable participants which supports its effectiveness against cUTI or acute pyelonephritis.
- In terms of safety profile across both studies, adverse events were reported but serum creatinine values remained stable over time indicating no significant renal toxicity associated with Plazomicin use; additionally no hearing loss was detected among evaluated participants suggesting a favorable ototoxicity profile as well.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Zemdri (plazomicin) Prescribing Information. | 2021 | 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 | New England Journal of Medicine |
| A multicenter, randomized, double-blind, phase 2 study of the efficacy and safety of plazomicin compared with levofloxacin in the treatment of complicated urinary tract infection and acute pyelonephritis. | 145Subjects F: 53% M: 47% | 2018 | Antimicrobial Agents and chemotherapy |
Sex Distribution:
F:53%
M:47%
388Subjects
Year:
2019
Source:New England Journal of Medicine
Sex Distribution:
F:53%
M:47%
145Subjects
Year:
2018
Source:Antimicrobial Agents and chemotherapy