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 / 감염과화학요법

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.

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 / 감염과화학요법

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.

Antimicrobial Activities of Tapocin(r) against Gram-Positive Cocci / 감염과화학요법

BACKGROUND: Recent hospital environments have changed, and the most common and important causative agents of nosocomial infections are Gram positive organisms, such as staphylococci, streptococci and enterococci. And increasing resistance of such Gram-positive organisms to antimicrobials, including glycopeptides, is causing big problems in hospital infections. Therefore, we confirmed and compared the antimicrobial activities of glycopeptides [Tapocin(r) (CJ Pharmaceutics. Korea), vancomycin, teicoplanin] against clinical isolates of streptococci(PSSP, PNSSP), staphylococci (MSSA, MRSA, MRCNS) and enterococci. METHODS: Total 666 strains of Gram-positive cocci, collected in five Catholic University affiliated Hospitals were tested by broth microdilution method using Muller-Hinton broth according to the recommendation of NCCLS (National Committee for Clinical Laboratory Standard, USA). RESULTS: In PSSP (n=46), MIC range of vancomycin was 0.25-0.5 microgram/mL, and that of Tapocin(r) and teicoplanin was equally 0.015-0.06 microgram/mL. MIC90 of vancomycin was 0.5 microgram/mL, and that of Tapocin(r) and teicoplanin was equally 0.06 microgram/mL. In PNSSP (n=123), MIC range of vancomycin was 0.25-0.5 microgram/mL, and MIC range of Tapocin(r) and teicoplanin was equally 0.03-0.06 microgram/mL. The MIC range of vancomycin against MSSA (n=116) was 2-4 microgram/mL, and that of Tapocin(r) and teicoplanin was equally 0.5-8 microgram/mL. MIC90 of vancomycin was 4 microgram/mL, and that of Tapocin(r) and teicoplanin was equally 2 microgram/mL. In MRSA (n=116), MIC range of Tapocin(r) and teicoplanin was equally 0.25-8 microgram /mL, showing broader range distribution than that of vancomycin (2-4 microgram/mL). MIC90 of vancomycin was 4 microgram/mL, and that of Tapocin(r) and teicoplanin was equally 8 microgram/mL. MIC range against MRCNS (n=14) of vancomycin was 0.25-8 microgram/mL, and that of Tapocin(r) and teicoplanin was equally 0.06- 16 microgram/mL. In enterococci (n=123), the MIC range of vancomycin was 0.5-64 microgram/mL, and that of Tapocin(r) and teicoplanin was equally 0.25-64 microgram/mL. MIC90 of all antibiotics was 8 microgram/mL, but 6 E. faecium resistant to all antibiotics were detected. CONCLUSION: The results of susceptibility tests showed that the against glycopeptides against Gram- positive cocci, which were isolated in our study university hospitals, seem to be largely unaffected. We also confirmed that the antimicrobial activity of Tapocin(r) was equal to that of teicoplanin.

Antimicrobial Activities of Tapocin(r) against Gram-Positive Cocci / 감염과화학요법

BACKGROUND: Recent hospital environments have changed, and the most common and important causative agents of nosocomial infections are Gram positive organisms, such as staphylococci, streptococci and enterococci. And increasing resistance of such Gram-positive organisms to antimicrobials, including glycopeptides, is causing big problems in hospital infections. Therefore, we confirmed and compared the antimicrobial activities of glycopeptides [Tapocin(r) (CJ Pharmaceutics. Korea), vancomycin, teicoplanin] against clinical isolates of streptococci(PSSP, PNSSP), staphylococci (MSSA, MRSA, MRCNS) and enterococci. METHODS: Total 666 strains of Gram-positive cocci, collected in five Catholic University affiliated Hospitals were tested by broth microdilution method using Muller-Hinton broth according to the recommendation of NCCLS (National Committee for Clinical Laboratory Standard, USA). RESULTS: In PSSP (n=46), MIC range of vancomycin was 0.25-0.5 microgram/mL, and that of Tapocin(r) and teicoplanin was equally 0.015-0.06 microgram/mL. MIC90 of vancomycin was 0.5 microgram/mL, and that of Tapocin(r) and teicoplanin was equally 0.06 microgram/mL. In PNSSP (n=123), MIC range of vancomycin was 0.25-0.5 microgram/mL, and MIC range of Tapocin(r) and teicoplanin was equally 0.03-0.06 microgram/mL. The MIC range of vancomycin against MSSA (n=116) was 2-4 microgram/mL, and that of Tapocin(r) and teicoplanin was equally 0.5-8 microgram/mL. MIC90 of vancomycin was 4 microgram/mL, and that of Tapocin(r) and teicoplanin was equally 2 microgram/mL. In MRSA (n=116), MIC range of Tapocin(r) and teicoplanin was equally 0.25-8 microgram /mL, showing broader range distribution than that of vancomycin (2-4 microgram/mL). MIC90 of vancomycin was 4 microgram/mL, and that of Tapocin(r) and teicoplanin was equally 8 microgram/mL. MIC range against MRCNS (n=14) of vancomycin was 0.25-8 microgram/mL, and that of Tapocin(r) and teicoplanin was equally 0.06- 16 microgram/mL. In enterococci (n=123), the MIC range of vancomycin was 0.5-64 microgram/mL, and that of Tapocin(r) and teicoplanin was equally 0.25-64 microgram/mL. MIC90 of all antibiotics was 8 microgram/mL, but 6 E. faecium resistant to all antibiotics were detected. CONCLUSION: The results of susceptibility tests showed that the against glycopeptides against Gram- positive cocci, which were isolated in our study university hospitals, seem to be largely unaffected. We also confirmed that the antimicrobial activity of Tapocin(r) was equal to that of teicoplanin.