Pharmacokinetic and clinical studies on teicoplanin for sepsis by methicillin-cephem resistant Staphylococcus aureus in the pediatric and neonate field

Keisuke Sunakawa, Masato Nonoyama, Naoichi Iwai, Yoshikiyo Toyonaga, Tomoaki Sano, Atsushi Naito, Kohji Shimura, Masanori Fujimura, Hiroyuki Kitajima, Katsura Fujinami, Yutaka Kobayashi, Tadafumi Nishimura, Takashi Motohiro, Ryochi Fujii, Hiroshi Sakata, Masaru Shirai, Takashi Sato, Mayumi Kajino, Kimio Minagawa, Yuichi Niida & 52 others Takanori Oda, Masato Yokozawa, Hideomi Asanuma, Kei Numazaki, Tomoko Fujikawa, Yoshitake Sato, Satoshi Iwata, Nihoko Tsuchihashi, Tomohiro Oishi, Shinji Matsumoto, Makiko Osawa, Mariko Sunahara, Seigo Shirakawa, Hiroshi Nishida, Naoto Takahashi, Reiji Nakano, Nobuaki Sai, Ichiro Tsukimoto, Osamu Motoyama, Wataru Sunaoshi, Shinya Nakamura, Yasuhisa Ueda, Tatsuo Kato, Mitsuo Chiba, Takeshi Horiuchi, Keiji Suzuki, Takenori Shimoyama, Hiroshi Masaki, Miho Aikyo, Momoko Kawada, Masahiro Banba, Shoichi Koizumi, Hideo Wada, Kazuhide Ohta, Takahiro Uehara, Satoshi Takakuwa, Kuniaki Iyoda, Kazunori Yoshimitsu, Kazunori Ogawa, Tomio Okazaki, Yoshiteru Takada, Masahiro Kawasaki, Masahiro Kamata, Kazunobu Ouchi, Shiro Sato, Seikyo Furukawa, Takashige Okada, Satoru Yamaguchi, Osamu Hirota, Ko Yukitake, Toshiko Mori, Kenji Matsuyama

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Pharmacokinetics, clinical efficacy and safety of teicoplanin (TEIC) were evaluated in pediatric and neonate patients with MRSA sepsis in the dosages approved in overseas. The administrated dose for pediatrics patients was 10 mg/kg once at hour 0, 12 and 24, followed by every 24 hours intervals. In neonates patients, first dose was 16 mg/kg, then 8 mg/kg every 24 hours intervals. 1. Pharmacokinetic results All 17 patients (9 neonates and 8 pediatrics) who received TEIC were evaluated for pharmacokinetics. Trough concentrations were analyzed in 16 patients (9 neonates and 7 pediatrics) excluding one patient for lack of measurement of drug concentration at day 7. No patient with a concentration exceeding 60 μg/mL in peak or trough concentrations were reported. Mean concentrations in trough at day 3, 4 and 7 in neonates were 15.2, 14.7 and 17.8 μg/mL, and in pediatrics were 12.5, 12.2 and 13.1 μg/mL, respectively. These results were similar to those reported in foreign pediatrics and neonates patients. 2. Efficacy and safety results Since no patient was excluded, all patients were evaluated for efficacy and safety. Microbiological efficacy as well as clinical cure were secondarily evaluated in 2 patients for whom MRSA was isolated from blood. Clinical efficacy rate was 76.5% (13/17) and number of cases in judgments of excellent, good, fairly improved and no change were 12, 1, 3 and 1 cases respectively. The patients for whom MRSA was isolated from blood were judged as MRSA eradicated case and cured without any additional anti-MRSA drugs. Adverse events were reported in 2 neonates and 3 pediatric patients. Possibly related adverse events to study drug (adverse drug reactions) were: 1 case of respiratory disorder, thrombocythemia, γ-GTP increased, GOT increased and GPT increased in 3 pediatrics. These results suggest that an application of overseas dose regimen of TEIC for neonate and pediatrics is appropriate in Japan.

Original languageEnglish
Pages (from-to)656-677
Number of pages22
JournalJapanese Journal of Antibiotics
Volume55
Issue number5
Publication statusPublished - 2002 Oct
Externally publishedYes

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Teicoplanin
Methicillin-Resistant Staphylococcus aureus
Sepsis
Pharmacokinetics
Newborn Infant
Pediatrics
Safety
Clinical Studies
Pharmaceutical Preparations
Thrombocytosis
Guanosine Triphosphate
Drug-Related Side Effects and Adverse Reactions

ASJC Scopus subject areas

  • Pharmacology
  • Molecular Medicine

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Pharmacokinetic and clinical studies on teicoplanin for sepsis by methicillin-cephem resistant Staphylococcus aureus in the pediatric and neonate field. / Sunakawa, Keisuke; Nonoyama, Masato; Iwai, Naoichi; Toyonaga, Yoshikiyo; Sano, Tomoaki; Naito, Atsushi; Shimura, Kohji; Fujimura, Masanori; Kitajima, Hiroyuki; Fujinami, Katsura; Kobayashi, Yutaka; Nishimura, Tadafumi; Motohiro, Takashi; Fujii, Ryochi; Sakata, Hiroshi; Shirai, Masaru; Sato, Takashi; Kajino, Mayumi; Minagawa, Kimio; Niida, Yuichi; Oda, Takanori; Yokozawa, Masato; Asanuma, Hideomi; Numazaki, Kei; Fujikawa, Tomoko; Sato, Yoshitake; Iwata, Satoshi; Tsuchihashi, Nihoko; Oishi, Tomohiro; Matsumoto, Shinji; Osawa, Makiko; Sunahara, Mariko; Shirakawa, Seigo; Nishida, Hiroshi; Takahashi, Naoto; Nakano, Reiji; Sai, Nobuaki; Tsukimoto, Ichiro; Motoyama, Osamu; Sunaoshi, Wataru; Nakamura, Shinya; Ueda, Yasuhisa; Kato, Tatsuo; Chiba, Mitsuo; Horiuchi, Takeshi; Suzuki, Keiji; Shimoyama, Takenori; Masaki, Hiroshi; Aikyo, Miho; Kawada, Momoko; Banba, Masahiro; Koizumi, Shoichi; Wada, Hideo; Ohta, Kazuhide; Uehara, Takahiro; Takakuwa, Satoshi; Iyoda, Kuniaki; Yoshimitsu, Kazunori; Ogawa, Kazunori; Okazaki, Tomio; Takada, Yoshiteru; Kawasaki, Masahiro; Kamata, Masahiro; Ouchi, Kazunobu; Sato, Shiro; Furukawa, Seikyo; Okada, Takashige; Yamaguchi, Satoru; Hirota, Osamu; Yukitake, Ko; Mori, Toshiko; Matsuyama, Kenji.

In: Japanese Journal of Antibiotics, Vol. 55, No. 5, 10.2002, p. 656-677.

Research output: Contribution to journalArticle

Sunakawa, K, Nonoyama, M, Iwai, N, Toyonaga, Y, Sano, T, Naito, A, Shimura, K, Fujimura, M, Kitajima, H, Fujinami, K, Kobayashi, Y, Nishimura, T, Motohiro, T, Fujii, R, Sakata, H, Shirai, M, Sato, T, Kajino, M, Minagawa, K, Niida, Y, Oda, T, Yokozawa, M, Asanuma, H, Numazaki, K, Fujikawa, T, Sato, Y, Iwata, S, Tsuchihashi, N, Oishi, T, Matsumoto, S, Osawa, M, Sunahara, M, Shirakawa, S, Nishida, H, Takahashi, N, Nakano, R, Sai, N, Tsukimoto, I, Motoyama, O, Sunaoshi, W, Nakamura, S, Ueda, Y, Kato, T, Chiba, M, Horiuchi, T, Suzuki, K, Shimoyama, T, Masaki, H, Aikyo, M, Kawada, M, Banba, M, Koizumi, S, Wada, H, Ohta, K, Uehara, T, Takakuwa, S, Iyoda, K, Yoshimitsu, K, Ogawa, K, Okazaki, T, Takada, Y, Kawasaki, M, Kamata, M, Ouchi, K, Sato, S, Furukawa, S, Okada, T, Yamaguchi, S, Hirota, O, Yukitake, K, Mori, T & Matsuyama, K 2002, 'Pharmacokinetic and clinical studies on teicoplanin for sepsis by methicillin-cephem resistant Staphylococcus aureus in the pediatric and neonate field', Japanese Journal of Antibiotics, vol. 55, no. 5, pp. 656-677.
Sunakawa, Keisuke ; Nonoyama, Masato ; Iwai, Naoichi ; Toyonaga, Yoshikiyo ; Sano, Tomoaki ; Naito, Atsushi ; Shimura, Kohji ; Fujimura, Masanori ; Kitajima, Hiroyuki ; Fujinami, Katsura ; Kobayashi, Yutaka ; Nishimura, Tadafumi ; Motohiro, Takashi ; Fujii, Ryochi ; Sakata, Hiroshi ; Shirai, Masaru ; Sato, Takashi ; Kajino, Mayumi ; Minagawa, Kimio ; Niida, Yuichi ; Oda, Takanori ; Yokozawa, Masato ; Asanuma, Hideomi ; Numazaki, Kei ; Fujikawa, Tomoko ; Sato, Yoshitake ; Iwata, Satoshi ; Tsuchihashi, Nihoko ; Oishi, Tomohiro ; Matsumoto, Shinji ; Osawa, Makiko ; Sunahara, Mariko ; Shirakawa, Seigo ; Nishida, Hiroshi ; Takahashi, Naoto ; Nakano, Reiji ; Sai, Nobuaki ; Tsukimoto, Ichiro ; Motoyama, Osamu ; Sunaoshi, Wataru ; Nakamura, Shinya ; Ueda, Yasuhisa ; Kato, Tatsuo ; Chiba, Mitsuo ; Horiuchi, Takeshi ; Suzuki, Keiji ; Shimoyama, Takenori ; Masaki, Hiroshi ; Aikyo, Miho ; Kawada, Momoko ; Banba, Masahiro ; Koizumi, Shoichi ; Wada, Hideo ; Ohta, Kazuhide ; Uehara, Takahiro ; Takakuwa, Satoshi ; Iyoda, Kuniaki ; Yoshimitsu, Kazunori ; Ogawa, Kazunori ; Okazaki, Tomio ; Takada, Yoshiteru ; Kawasaki, Masahiro ; Kamata, Masahiro ; Ouchi, Kazunobu ; Sato, Shiro ; Furukawa, Seikyo ; Okada, Takashige ; Yamaguchi, Satoru ; Hirota, Osamu ; Yukitake, Ko ; Mori, Toshiko ; Matsuyama, Kenji. / Pharmacokinetic and clinical studies on teicoplanin for sepsis by methicillin-cephem resistant Staphylococcus aureus in the pediatric and neonate field. In: Japanese Journal of Antibiotics. 2002 ; Vol. 55, No. 5. pp. 656-677.
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abstract = "Pharmacokinetics, clinical efficacy and safety of teicoplanin (TEIC) were evaluated in pediatric and neonate patients with MRSA sepsis in the dosages approved in overseas. The administrated dose for pediatrics patients was 10 mg/kg once at hour 0, 12 and 24, followed by every 24 hours intervals. In neonates patients, first dose was 16 mg/kg, then 8 mg/kg every 24 hours intervals. 1. Pharmacokinetic results All 17 patients (9 neonates and 8 pediatrics) who received TEIC were evaluated for pharmacokinetics. Trough concentrations were analyzed in 16 patients (9 neonates and 7 pediatrics) excluding one patient for lack of measurement of drug concentration at day 7. No patient with a concentration exceeding 60 μg/mL in peak or trough concentrations were reported. Mean concentrations in trough at day 3, 4 and 7 in neonates were 15.2, 14.7 and 17.8 μg/mL, and in pediatrics were 12.5, 12.2 and 13.1 μg/mL, respectively. These results were similar to those reported in foreign pediatrics and neonates patients. 2. Efficacy and safety results Since no patient was excluded, all patients were evaluated for efficacy and safety. Microbiological efficacy as well as clinical cure were secondarily evaluated in 2 patients for whom MRSA was isolated from blood. Clinical efficacy rate was 76.5{\%} (13/17) and number of cases in judgments of excellent, good, fairly improved and no change were 12, 1, 3 and 1 cases respectively. The patients for whom MRSA was isolated from blood were judged as MRSA eradicated case and cured without any additional anti-MRSA drugs. Adverse events were reported in 2 neonates and 3 pediatric patients. Possibly related adverse events to study drug (adverse drug reactions) were: 1 case of respiratory disorder, thrombocythemia, γ-GTP increased, GOT increased and GPT increased in 3 pediatrics. These results suggest that an application of overseas dose regimen of TEIC for neonate and pediatrics is appropriate in Japan.",
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T1 - Pharmacokinetic and clinical studies on teicoplanin for sepsis by methicillin-cephem resistant Staphylococcus aureus in the pediatric and neonate field

AU - Sunakawa, Keisuke

AU - Nonoyama, Masato

AU - Iwai, Naoichi

AU - Toyonaga, Yoshikiyo

AU - Sano, Tomoaki

AU - Naito, Atsushi

AU - Shimura, Kohji

AU - Fujimura, Masanori

AU - Kitajima, Hiroyuki

AU - Fujinami, Katsura

AU - Kobayashi, Yutaka

AU - Nishimura, Tadafumi

AU - Motohiro, Takashi

AU - Fujii, Ryochi

AU - Sakata, Hiroshi

AU - Shirai, Masaru

AU - Sato, Takashi

AU - Kajino, Mayumi

AU - Minagawa, Kimio

AU - Niida, Yuichi

AU - Oda, Takanori

AU - Yokozawa, Masato

AU - Asanuma, Hideomi

AU - Numazaki, Kei

AU - Fujikawa, Tomoko

AU - Sato, Yoshitake

AU - Iwata, Satoshi

AU - Tsuchihashi, Nihoko

AU - Oishi, Tomohiro

AU - Matsumoto, Shinji

AU - Osawa, Makiko

AU - Sunahara, Mariko

AU - Shirakawa, Seigo

AU - Nishida, Hiroshi

AU - Takahashi, Naoto

AU - Nakano, Reiji

AU - Sai, Nobuaki

AU - Tsukimoto, Ichiro

AU - Motoyama, Osamu

AU - Sunaoshi, Wataru

AU - Nakamura, Shinya

AU - Ueda, Yasuhisa

AU - Kato, Tatsuo

AU - Chiba, Mitsuo

AU - Horiuchi, Takeshi

AU - Suzuki, Keiji

AU - Shimoyama, Takenori

AU - Masaki, Hiroshi

AU - Aikyo, Miho

AU - Kawada, Momoko

AU - Banba, Masahiro

AU - Koizumi, Shoichi

AU - Wada, Hideo

AU - Ohta, Kazuhide

AU - Uehara, Takahiro

AU - Takakuwa, Satoshi

AU - Iyoda, Kuniaki

AU - Yoshimitsu, Kazunori

AU - Ogawa, Kazunori

AU - Okazaki, Tomio

AU - Takada, Yoshiteru

AU - Kawasaki, Masahiro

AU - Kamata, Masahiro

AU - Ouchi, Kazunobu

AU - Sato, Shiro

AU - Furukawa, Seikyo

AU - Okada, Takashige

AU - Yamaguchi, Satoru

AU - Hirota, Osamu

AU - Yukitake, Ko

AU - Mori, Toshiko

AU - Matsuyama, Kenji

PY - 2002/10

Y1 - 2002/10

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AB - Pharmacokinetics, clinical efficacy and safety of teicoplanin (TEIC) were evaluated in pediatric and neonate patients with MRSA sepsis in the dosages approved in overseas. The administrated dose for pediatrics patients was 10 mg/kg once at hour 0, 12 and 24, followed by every 24 hours intervals. In neonates patients, first dose was 16 mg/kg, then 8 mg/kg every 24 hours intervals. 1. Pharmacokinetic results All 17 patients (9 neonates and 8 pediatrics) who received TEIC were evaluated for pharmacokinetics. Trough concentrations were analyzed in 16 patients (9 neonates and 7 pediatrics) excluding one patient for lack of measurement of drug concentration at day 7. No patient with a concentration exceeding 60 μg/mL in peak or trough concentrations were reported. Mean concentrations in trough at day 3, 4 and 7 in neonates were 15.2, 14.7 and 17.8 μg/mL, and in pediatrics were 12.5, 12.2 and 13.1 μg/mL, respectively. These results were similar to those reported in foreign pediatrics and neonates patients. 2. Efficacy and safety results Since no patient was excluded, all patients were evaluated for efficacy and safety. Microbiological efficacy as well as clinical cure were secondarily evaluated in 2 patients for whom MRSA was isolated from blood. Clinical efficacy rate was 76.5% (13/17) and number of cases in judgments of excellent, good, fairly improved and no change were 12, 1, 3 and 1 cases respectively. The patients for whom MRSA was isolated from blood were judged as MRSA eradicated case and cured without any additional anti-MRSA drugs. Adverse events were reported in 2 neonates and 3 pediatric patients. Possibly related adverse events to study drug (adverse drug reactions) were: 1 case of respiratory disorder, thrombocythemia, γ-GTP increased, GOT increased and GPT increased in 3 pediatrics. These results suggest that an application of overseas dose regimen of TEIC for neonate and pediatrics is appropriate in Japan.

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