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Randomized Controlled Trial to Determine the Efficacy of Early Switch from Vancomycin to Vancomycin Alternatives as a Strategy to Prevent Nephrotoxicity in Patients with Multiple Risk Factors for Adverse Renal Outcomes (STOP-NT)
Carreno JJ, Kenney RM, Divine G, et al. Ann Pharmacother. 2017; 51: 185-93.
Study Question: What is the efficacy of early switch from vancomycin to non-nephrotoxic alternative antimicrobial agents (AAA) in preventing acute kidney injury (AKI) in patients at high risk for AKI?
Study Description: This single-center, randomized controlled trial was performed in adult patients receiving vancomycin with at least 2 pre-specified risk factors for AKI: (1) ≥ 4 g of vancomycin daily or total body weight ≥ 110 kg, (2) pre-existing renal dysfunction, (3) concurrent IV vasopressor use, and (4) concurrent nephrotoxic medication use. Exclusion criteria were an absolute neutrophil count < 1000 cells/mm3, end-stage renal disease, active AKI, administration of ≥ 4 g of vancomycin during the hospitalization prior to enrollment, and pregnancy. Randomization to either dose-optimized vancomycin or to an AAA (linezolid, daptomycin, or ceftaroline) was done based on infection and indication for vancomycin. The primary outcome was incidence of nephrotoxicity. The secondary endpoints were nephrotoxicity based on AKI Network (AKIN) criteria, 30-day mortality, and clinical cure. Analysis was performed on modified intent-to-treat (mITT).
Results: One hundred patients were randomized: 49 received AAA and 51 received vancomycin. Median duration of therapy was approximately 7 days in each group. There were no significant differences in incidence of nephrotoxicity or in nephrotoxicity by AKIN criteria (6.1% AAA vs 9.8% vancomycin, p = 0.72 and 32.7% AAA vs 31.4%, p = 0.89, respectively). Clinical cure rates and 30-day all-cause mortality did not differ significantly between groups.
Conclusion(s): Early switch from vancomycin to AAA in patients without baseline AKI but at high risk for AKI was not associated with a reduced incidence of nephrotoxicity.
Perspective: Although the effects of specific medications on AKI rates and serial risk assessments from baseline to end of treatment were not directly evaluated, empirically switching from vancomycin to AAA strictly for renal-protection should not be pursued. There may remain a benefit to early switching when risk factors associated with higher AKI rates, either alone or in combination, are present such as multiple concomitant nephrotoxic medications, as AKI risk increases or for anticipated prolonged antimicrobial courses.