A Randomized, Phase IV, Comparison Study on the Efficacy and Safety of Tapocin(R) and Targocid(R) in Treating Infections Caused by Multi-Resistant Gram Positive Cocci.
- Author:
Dae Won PARK
1
;
Hye Won JEONG
;
Sung Joo JUNG
;
Sae Yoon KEE
;
Jung Yeon KIM
;
Young Mi KIM
;
Seong Il KIM
;
Sung Eun LEE
;
Byung Chul CHUN
;
Min Ja KIM
Author Information
1. Division of Infectious Diseases, Department of Internal Medicine, College of Medicine, Korea University, Seoul, Korea. macropha@korea.ac.kr
- Publication Type:Clinical Trial ; Original Article ; Randomized Controlled Trial
- Keywords:
Tapocin;
Teicoplanin;
Clinical trial;
Multi-drug resistant gram positive cocci
- MeSH:
Adult;
Arm;
Fever;
Gram-Positive Cocci*;
Humans;
Korea;
Methicillin-Resistant Staphylococcus aureus;
Sex Ratio;
Teicoplanin
- From:
Infection and Chemotherapy
2005;37(4):193-198
- CountryRepublic of Korea
- Language:Korean
-
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.
