A Multicentre, Open label, Randomized, Comparative, Parallel Group, Active-controlled, Phase III Clinical Trial to Evaluate Safety and Efficacy of Arbekacin Sulphate Injection versus Vancomycin Injection in Patients Diagnosed with MRSA Infection

摘要

Background: Increasing resistance to currently available antimicrobials has led tothe development of new agents. Arbekacin is aminoglycoside antibiotic currentlyused in Japan and Korea for the treatment of infections caused by multi-resistantbacteria including MRSA. Currently there is no published data available for useof Arbekacin in Indian patient population, thus the present study was conductedto evaluate the safety and efficacy of Arbekacin in Indian population.Material and Methods: The study was a phase III, multi-centre, open-label,randomised comparative, active control study. Subjects with microbiologicallyconfirmed MRSA infection were randomized in the study to receive eitherArbekacin sulphate 200 mg OD or Vancomycin hydrochloride 1000 mg BD fora period of 7 to 14 days. The primary endpoint was to evaluate the overall curerate i.e. Clinical and microbiological cure during the study.Results: A total of 162 patients were randomized in 2 treatment groups (i.e. 81patients in each group). Out of these microbiologically confirmed MRSA patients,153 patients were admitted for SSTI while 9 patients were admitted for CAP.Overall cure rate of MRSA infection (clinical as well as microbiological cure) wascomparable in both the treatment groups i.e. 97.5% (79/81) in Arbekacin groupand 100 % (79/79) in Vancomycin group (p value: 0.159). Both Arbekacin andVancomycin were well tolerated by the patients during the study period.Conclusion: Arbekacin can be considered as safe and effective alternative tovancomycin in the management of MRSA infections.