Use of
vancomycin has increased following the emergence of resistant
Gram-positive bacterial infections. Investigation into recent
vancomycin clinical studies provides insight into the optimal use of
vancomycin and the development of novel
antibiotics for the treatment of resistant
infections. Interventional
vancomycin trials registered in ClinicalTrials.gov from January 1999 to December 2012 were identified. Trial trends and characteristics were evaluated in the context of
vancomycin use and new
antibiotic development. Overall, 122 interventional
vancomycin trials were identified, with a significant increase in the number of registered trials per year (P<0.001). The top three indications studied were skin and
soft-tissue infections (28.7%),
Clostridium difficile infections (13.1%) and surgical prophylaxis (12.3%). Trials testing
vancomycin as an experimental agent differed from trials using
vancomycin as an active comparator. Experimental agent trials commonly investigated new formulations, dosing regimen optimisation and combination
therapy, which were less likely to be in phase 2 or 3 (25% vs. 70%; P<0.001), adopt a randomisation procedure (70% vs. 98%; P<0.001), report results (15% vs. 35%; P=0.02) or be funded by industry (8% vs. 76%; P<0.001). Active comparator trials mainly focused on monotherapy, which led to six FDA-approved
drug products and ten
investigational new drugs in late-phase development. This study demonstrated a significant increase in interventional
vancomycin trials and its recent success, which resulted in several novel agents against resistant Gram-positive bacteria. Further studies are warranted to determine how these agents can best be incorporated within clinical practice.