Clinical study of meropenem for infections in the pediatric field

Yoshikiyo Toyonaga, Keisuke Sunakawa, Takashi Motohiro, Naoishi Iwai, Yusuke Tanigawara, Hiroko Endo, Yashitake Sato, Haruo Kuroki, Masanori Minagawa, Naruhiko Ishiwada, Takeshi Tajima, Satoshi Iwata, Hideo Cho, Wataru Sunaoshi, Tatsuo Kato, Masahiro Bamba, Eiji Wakamiya, Kumiko Sugita, Takeshi Yamazaki, Naohisa KawamuraTsunekazu Haruta, Seikyou Furukawa, Takashige Okada, Tamotsu Fujimoto, Takanobu Ishihara, Akikazu Ando, Naoli Tsumura

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

The purpose of this study was to evaluate the efficacy, safety and PK profile of meropenem (MEPM) in the treatment of hospitalized infants and children with various infections. A total 52 patients, average 3.48 years old, were enrolled in the study. MEPM was administered intravenously every 8 hours at a daily dose of 10, 20 or 40 mg/kg. The overall favorable clinical response rate was 95.9% (47 out of 49 eligible patients). The breakdown of the clinical response rate was 96.2% (25/26) for RTI, 100% (6/6) for sepsis, 100% (5/5) for meningitis, 100% (3/3) for UTI and 88.9% (8/9) for the other infections. There were no sequelae or mortality in five cases of meningitis treated with 40 mg/kg MEPM. The microbiological response was satisfactory in 97.0% (30 cases of "Eradicated" plus 2 cases of "Presumed eradicated" out of 33 evaluable patients). The two most frequently isolated bacteria were Streptococcus pneumoniae (16 strains) and Haemophilus influenzae (21 strains). These strains were favorably susceptible to MEPM. Plasma MEPM concentrations at 20-30 min after infusion were 65.52-38.22 μg/mL on 40 mg/kg, 30.81-13.73 μg/mL on 20 mg/kg and 16.37-5.86 μg/mL on 10 mg/kg, respectively. Urinary recovery was 56.4-70.7% after administration up to 8 hours. Cerebrospinal fluid (CSF) MEPM level was sustained at 0.29-2.75 μg/mL up to 6 hours in the meningitis patients at a dose of 40 mg/kg. There were adverse drug reactions in 23 out of 52 patients, but no severe incidence was observed. In conclusion, MEPM appeared to be a useful agent for treatment of common infentions in infant and child patients at a dose of 10 or 20 mg/kg three times daily, and for severe infections such as meningitis at a dose of 40 mg/kg.

Original languageEnglish
Pages (from-to)762-781
Number of pages20
JournalJapanese Journal of Chemotherapy
Volume51
Issue number12
Publication statusPublished - 2003 Dec

Fingerprint

meropenem
Pediatrics
Meningitis
Infection
Hospitalized Child
Haemophilus influenzae
Streptococcus pneumoniae
Clinical Studies
Drug-Related Side Effects and Adverse Reactions
Cerebrospinal Fluid
Sepsis

Keywords

  • Meropenem

ASJC Scopus subject areas

  • Pharmacology

Cite this

Toyonaga, Y., Sunakawa, K., Motohiro, T., Iwai, N., Tanigawara, Y., Endo, H., ... Tsumura, N. (2003). Clinical study of meropenem for infections in the pediatric field. Japanese Journal of Chemotherapy, 51(12), 762-781.

Clinical study of meropenem for infections in the pediatric field. / Toyonaga, Yoshikiyo; Sunakawa, Keisuke; Motohiro, Takashi; Iwai, Naoishi; Tanigawara, Yusuke; Endo, Hiroko; Sato, Yashitake; Kuroki, Haruo; Minagawa, Masanori; Ishiwada, Naruhiko; Tajima, Takeshi; Iwata, Satoshi; Cho, Hideo; Sunaoshi, Wataru; Kato, Tatsuo; Bamba, Masahiro; Wakamiya, Eiji; Sugita, Kumiko; Yamazaki, Takeshi; Kawamura, Naohisa; Haruta, Tsunekazu; Furukawa, Seikyou; Okada, Takashige; Fujimoto, Tamotsu; Ishihara, Takanobu; Ando, Akikazu; Tsumura, Naoli.

In: Japanese Journal of Chemotherapy, Vol. 51, No. 12, 12.2003, p. 762-781.

Research output: Contribution to journalArticle

Toyonaga, Y, Sunakawa, K, Motohiro, T, Iwai, N, Tanigawara, Y, Endo, H, Sato, Y, Kuroki, H, Minagawa, M, Ishiwada, N, Tajima, T, Iwata, S, Cho, H, Sunaoshi, W, Kato, T, Bamba, M, Wakamiya, E, Sugita, K, Yamazaki, T, Kawamura, N, Haruta, T, Furukawa, S, Okada, T, Fujimoto, T, Ishihara, T, Ando, A & Tsumura, N 2003, 'Clinical study of meropenem for infections in the pediatric field', Japanese Journal of Chemotherapy, vol. 51, no. 12, pp. 762-781.
Toyonaga Y, Sunakawa K, Motohiro T, Iwai N, Tanigawara Y, Endo H et al. Clinical study of meropenem for infections in the pediatric field. Japanese Journal of Chemotherapy. 2003 Dec;51(12):762-781.
Toyonaga, Yoshikiyo ; Sunakawa, Keisuke ; Motohiro, Takashi ; Iwai, Naoishi ; Tanigawara, Yusuke ; Endo, Hiroko ; Sato, Yashitake ; Kuroki, Haruo ; Minagawa, Masanori ; Ishiwada, Naruhiko ; Tajima, Takeshi ; Iwata, Satoshi ; Cho, Hideo ; Sunaoshi, Wataru ; Kato, Tatsuo ; Bamba, Masahiro ; Wakamiya, Eiji ; Sugita, Kumiko ; Yamazaki, Takeshi ; Kawamura, Naohisa ; Haruta, Tsunekazu ; Furukawa, Seikyou ; Okada, Takashige ; Fujimoto, Tamotsu ; Ishihara, Takanobu ; Ando, Akikazu ; Tsumura, Naoli. / Clinical study of meropenem for infections in the pediatric field. In: Japanese Journal of Chemotherapy. 2003 ; Vol. 51, No. 12. pp. 762-781.
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AU - Toyonaga, Yoshikiyo

AU - Sunakawa, Keisuke

AU - Motohiro, Takashi

AU - Iwai, Naoishi

AU - Tanigawara, Yusuke

AU - Endo, Hiroko

AU - Sato, Yashitake

AU - Kuroki, Haruo

AU - Minagawa, Masanori

AU - Ishiwada, Naruhiko

AU - Tajima, Takeshi

AU - Iwata, Satoshi

AU - Cho, Hideo

AU - Sunaoshi, Wataru

AU - Kato, Tatsuo

AU - Bamba, Masahiro

AU - Wakamiya, Eiji

AU - Sugita, Kumiko

AU - Yamazaki, Takeshi

AU - Kawamura, Naohisa

AU - Haruta, Tsunekazu

AU - Furukawa, Seikyou

AU - Okada, Takashige

AU - Fujimoto, Tamotsu

AU - Ishihara, Takanobu

AU - Ando, Akikazu

AU - Tsumura, Naoli

PY - 2003/12

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N2 - The purpose of this study was to evaluate the efficacy, safety and PK profile of meropenem (MEPM) in the treatment of hospitalized infants and children with various infections. A total 52 patients, average 3.48 years old, were enrolled in the study. MEPM was administered intravenously every 8 hours at a daily dose of 10, 20 or 40 mg/kg. The overall favorable clinical response rate was 95.9% (47 out of 49 eligible patients). The breakdown of the clinical response rate was 96.2% (25/26) for RTI, 100% (6/6) for sepsis, 100% (5/5) for meningitis, 100% (3/3) for UTI and 88.9% (8/9) for the other infections. There were no sequelae or mortality in five cases of meningitis treated with 40 mg/kg MEPM. The microbiological response was satisfactory in 97.0% (30 cases of "Eradicated" plus 2 cases of "Presumed eradicated" out of 33 evaluable patients). The two most frequently isolated bacteria were Streptococcus pneumoniae (16 strains) and Haemophilus influenzae (21 strains). These strains were favorably susceptible to MEPM. Plasma MEPM concentrations at 20-30 min after infusion were 65.52-38.22 μg/mL on 40 mg/kg, 30.81-13.73 μg/mL on 20 mg/kg and 16.37-5.86 μg/mL on 10 mg/kg, respectively. Urinary recovery was 56.4-70.7% after administration up to 8 hours. Cerebrospinal fluid (CSF) MEPM level was sustained at 0.29-2.75 μg/mL up to 6 hours in the meningitis patients at a dose of 40 mg/kg. There were adverse drug reactions in 23 out of 52 patients, but no severe incidence was observed. In conclusion, MEPM appeared to be a useful agent for treatment of common infentions in infant and child patients at a dose of 10 or 20 mg/kg three times daily, and for severe infections such as meningitis at a dose of 40 mg/kg.

AB - The purpose of this study was to evaluate the efficacy, safety and PK profile of meropenem (MEPM) in the treatment of hospitalized infants and children with various infections. A total 52 patients, average 3.48 years old, were enrolled in the study. MEPM was administered intravenously every 8 hours at a daily dose of 10, 20 or 40 mg/kg. The overall favorable clinical response rate was 95.9% (47 out of 49 eligible patients). The breakdown of the clinical response rate was 96.2% (25/26) for RTI, 100% (6/6) for sepsis, 100% (5/5) for meningitis, 100% (3/3) for UTI and 88.9% (8/9) for the other infections. There were no sequelae or mortality in five cases of meningitis treated with 40 mg/kg MEPM. The microbiological response was satisfactory in 97.0% (30 cases of "Eradicated" plus 2 cases of "Presumed eradicated" out of 33 evaluable patients). The two most frequently isolated bacteria were Streptococcus pneumoniae (16 strains) and Haemophilus influenzae (21 strains). These strains were favorably susceptible to MEPM. Plasma MEPM concentrations at 20-30 min after infusion were 65.52-38.22 μg/mL on 40 mg/kg, 30.81-13.73 μg/mL on 20 mg/kg and 16.37-5.86 μg/mL on 10 mg/kg, respectively. Urinary recovery was 56.4-70.7% after administration up to 8 hours. Cerebrospinal fluid (CSF) MEPM level was sustained at 0.29-2.75 μg/mL up to 6 hours in the meningitis patients at a dose of 40 mg/kg. There were adverse drug reactions in 23 out of 52 patients, but no severe incidence was observed. In conclusion, MEPM appeared to be a useful agent for treatment of common infentions in infant and child patients at a dose of 10 or 20 mg/kg three times daily, and for severe infections such as meningitis at a dose of 40 mg/kg.

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