Drug updated on 9/4/2024
Dosage Form | Injection (intravenous; 2 g/vial [1 g meropenem (equivalent to 1.14 g meropenem trihydrate) and 1 g vaborbactam]) |
Drug Class | Antibacterials |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible bacteria.
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Summary
- Vabomere (meropenem and vaborbactam) is indicated for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI), including pyelonephritis caused by designated susceptible bacteria.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- The intervention group demonstrated a higher Clinical Cure Rate (CCR) at Test of Cure (TOC) compared to the control group (83.6% vs. 80.3%, OR 1.37, 95% CI 1.08-1.74, P=0.01), and a higher microbiological eradication rate at TOC (77.7% vs. 67.2%, OR 1.79, 95% CI 1.46-2.20, P<0.00001).
- Meropenem/vaborbactam (MV), ertapenem (ETPM), and biapenem (BAPM) were associated with higher clinical and microbiological treatment success rates compared to other carbapenems, with doripenem (DOPM) showing lower clinical treatment success rates.
- Meropenem/vaborbactam (MV) was particularly effective in treating complicated urinary tract infections (cUTI) caused by carbapenem-resistant uropathogens, making it a significant option for this specific population subgroup.
- No significant difference in the risk of treatment-emergent adverse events (AEs) between the intervention and control groups was observed (OR 0.95, P=0.57).
- Meropenem/vaborbactam (MV) and imipenem/cilastatin (IC) had higher risks of adverse events compared to other carbapenems.
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Vabomere (meropenem and vaborbactam) Prescribing Information. | 2023 | Melinta Therapeutics, LLC., Lincolnshire, IL |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Clinical efficacy and safety of novel antibiotics for complicated urinary tract infection: a systematic review and meta-analysis of randomized controlled trials. | 2023 | International Journal of Antimicrobial Agents |
Carbapenems vs alternative antibiotics for the treatment of complicated urinary tract infection. | 2020 | Medicine Open |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Infectious Diseases Society of America 2023 guidance on the treatment of antimicrobial resistant gram-negative infections. | 2023 | Infectious Disease Society of America |
Infectious Diseases Society of America guidance on the treatment of extended-spectrum β-lactamase producing enterobacterales (ESBL-E), carbapenem-resistant enterobacterales (CRE), and Pseudomonas aeruginosa with difficult-to-treat resistance (DTR-P. aeruginosa). | 2021 | Clinical Infectious Diseases |