Clinical Outcomes of Patient Subgroups in the TANGO II Study

• Published in: Infectious diseases and therapy Vol. 10; no. 1; pp. 35 - 46
• Main Author: Bhowmick, Tanaya
• Format: Journal Article
• Language: English
• Published: Cheshire Springer Healthcare 01.03.2021; Springer; Springer Nature B.V
• Subjects: Antibiotics; Care and treatment; Clinical outcomes; Commentary; Comorbidity; Development and progression; Infections; Infectious Diseases; Information management; Internal Medicine; Medical research; Medicine; Medicine & Public Health; Medicine, Experimental; Patient outcomes; Patients; Practice; Skin; The Place of Meropenem-Vaborbactam in the Management of Carbapenem-Resistant Gram-Negative Infections; Urinary tract infections; Vabomere; Carbapenem-resistant organisms; Multidrug-resistant organisms; Meropenem–vaborbactam
• ISSN: 2193-8229; 2193-6382; 2193-6382
• DOI: 10.1007/s40121-021-00405-x

Introduction Meropenem–vaborbactam (M-V), a new approved antimicrobial, was developed specifically to be effective treatment for the increasingly prevalent and difficult to treat carbapenem-resistant Enterobacterales (CRE) infections. However, registration phase 3 clinical studies offer limited applicability to daily medical practice as they often focus on indications such as urinary tract infections or skin and soft tissue infections, which generally have patients with fewer comorbid conditions that the typical patients who develops infection with CRE. The more useful studies are pathogen-focused trials which do not exclude the more complicated subjects with conditions such as renal failure, immunocompromised status, or exposure to prior antibiotic therapy. Methods The TANGO II study was an open-label investigation of M-V compared with the best available treatment (BAT) in hospitalized adults with a confirmed infection that was known or suspected to be a CRE infection. TANGO II specifically included patients with comorbidities, prior antibiotic therapy, renal failure, and immunocompromised status that are typical in patients with a CRE infection. Interim data analysis indicated that a significant benefit was seen for those patients receiving M-V over BAT. This analysis reports on subsets of TANGO II study patients with multiple comorbidities and high severity of illness, specifically those with prior antibiotic therapy, renal failure, and immunocompromised status. A patient case that highlights particular complexities and challenges of treating patients with CRE infections in the real world is also presented. Results Subjects with comorbid conditions had better outcomes when given M-V rather than BAT. Conclusion M-V is a welcome addition to the antibiotic armamentarium for the treatment of severe CRE infections in complicated patients. Trial Registration ClinicalTrials.gov identifier NCT02168946.