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Infect Chemother. 2005 Aug;37(4):193-198. Korean. Clinical Trial.
Park DW , Jeong HW , Jung SJ , Kee SY , Kim JY , Kim YM , Kim SI , Lee SE , Chun BC , Kim MJ .
Division of Infectious Diseases, Department of Internal Medicine, College of Medicine, Korea University, Seoul, Korea. macropha@korea.ac.kr
Department of Pharmacy, College of Medicine, Korea University, Seoul, Korea.
Department of Clinical Pathology, College of Medicine, Korea University, Seoul, Korea.
Department of Infection Control Unit, Korea University Anam Hospital, College of Medicine, Korea University, Seoul, Korea.
Department of Preventive Medicine, College of Medicine, Korea University, Seoul, Korea.
Abstract

BACKGROUND: Tapocin(R) is a recently produced Teicoplanin in Korea. To evaluate its clinical usefulness, we compared clinical outcome and safety of Tapocin(R) with those of Teicoplanin (Targocid(R)) against infection caused by multi-drug resistant gram positive cocci. MATERIALS AND METHODS: Twenty-four adult patients infected with multi-drug resistant gram positive cocci were enrolled and randomized into each treatment arm after informed consents were obtained. All patients were given one of the test articles for 7 to 14 days intravenously. Clinical outcome and safety were compared between the two groups. Statistical analysis was done by Chi-square test, Student's t-test, and Fisher's exact test. RESULTS: Twenty out of 24 enrolled patients could be evaluated for clinical efficacy and safety (10 patients for each treatment arm). The baseline characteristics were not significantly different between the two groups in terms of mean age, sex ratio, underlying diseases, site of infections, and causative microorganisms. MRSA was the most common organism: 66.67% in Tarpocin(R) and 91.67% in Targocid(R) groups. Total doses of Targocid(R) and Tapocin(R) administered were 24 and 23 vials, respectively. Fever resolved in 90% of treated subjects and there were no significant differences between the two groups. Bacteriological response shows that the causative microorganisms were eradicated except for one MRSA isolate from each group. Drug fever, as a side effect, was reported from one subject in each group. CONCLUSION: Efficacy and safety of Tapocin(R) is comparable to those of Targocid(R) for the treatment of infections with multi-drug resistant gram-positive cocci.

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