Drug updated on 9/4/2024
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
- Zemdri (plazomicin) is indicated for the treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI), including pyelonephritis.
- This summary is based on the review of one randomized controlled trial(s). [1]
- Day 5 Composite Cure Rates for complicated UTIs and acute pyelonephritis: Plazomicin achieved a cure rate of 88.0% (168/191) compared to 91.4% (180/197) with meropenem, with a difference of -3.4 percentage points (95% CI, -10.0 to 3.1).
- Test-of-Cure Composite Cure Rates (15 to 19 days after initiation): Plazomicin had a cure rate of 81.7% (156/191) versus 70.1% (138/197) with meropenem, showing a difference of 11.6 percentage points (95% CI, 2.7 to 20.3).
- Late Follow-Up Outcomes (24 to 32 days after initiation): Plazomicin resulted in lower microbiologic recurrence (3.7%) and clinical relapse (1.6%) compared to meropenem, which had rates of 8.1% and 7.1%, respectively.
- An increase in serum creatinine levels (≥0.5 mg/dL above baseline) was observed in 7.0% of patients treated with plazomicin, compared to 4.0% in those treated with meropenem.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Zemdri (plazomicin) Prescribing Information. | 2020 | 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 |
Sex Distribution:
F:53%
M:47%
388Subjects
Year:
2019
Source:New England Journal of Medicine