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.

BACKGROUND: Increasing resistance to currently available antimicrobials has led to the development of new agents. Arbekacin is aminoglycoside antibiotic currently used in Japan and Korea for the treatment of infections caused by multi-resistant bacteria including MRSA. Currently there is no published data available for use of Arbekacin in Indian patient population, thus the present study was conducted to 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 microbiologically confirmed MRSA infection were randomized in the study to receive either Arbekacin sulphate 200 mg OD or Vancomycin hydrochloride 1000 mg BD for a period of 7 to 14 days. The primary endpoint was to evaluate the overall cure rate i.e. Clinical and microbiological cure during the study. RESULTS: A total of 162 patients were randomized in 2 treatment groups (i.e. 81 patients 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) was comparable in both the treatment groups i.e. 97.5% (79/81) in Arbekacin group and 100 % (79/79) in Vancomycin group (p value: 0.159). Both Arbekacin and Vancomycin were well tolerated by the patients during the study period. CONCLUSION: Arbekacin can be considered as safe and effective alternative to vancomycin in the management of MRSA infections.

Comparative Analysis between Podography and Radiography in the Management of Idiopathic Clubfeet by Ponseti Technique.

INTRODUCTION: Idiopathic clubfoot is one of the most common and oldest congenital foot anomalies. There are controversies regarding its optimum management protocol and methodologies to be employed for its functional outcome evaluation. This paper attempts to propose a simple, reasonable and easily reproducible technique of podography for clinical and functional evaluation of clubfoot treated by the popular Ponseti technique. AIM: To compare the Foot Bimalleolar (FBM) angle method (podography) and radiography with respect to management of idiopathic clubfoot by Ponseti's Technique and its functional evaluation. MATERIALS AND METHODS: Sixty feet of 48 patients with idiopathic clubfoot deformity were assessed in terms of FBM by podography (foot print on paper and FBM angle drawing) and radiologically; before starting treatment, after 6 weeks and at 6 monthly intervals with a maximum follow up period of 4.8 years (Range 1.2 to 4.8 years). Mean age at start of treatment was 1.5 years (2 months to 2.5 years). Functional evaluation was done by Magone's scoring system. RESULTS: After treatment, 92 percent patients had good correction (FBM greater than 70 degrees) which correlated well with post treatment Magone's score of greater than 80 (good to excellent) in nearly 85 percent of cases. Radiologically, talocalcaneal angles in both the views improved in only 60 percent of cases. CONCLUSION: Radiological criteria show inconsistent correlation with functional outcome for feet treated by Ponseti's Technique. Podography (FBM angle analysis) is a very simple, objective, cost effective, radiation free, easily reproducible and highly reliable clinical criterion for the assessment of deformity correction in club foot by Ponseti's Technique with an excellent correlation with functional outcome.