Open-label study to evaluate the pharmacodynamics, clinical efficacy, and safety of meropenem for adult bacterial meningitis in Japan
Abstract The aim of this study was to assess the efficacy, safety, and concentration of meropenem in cerebrospinal fluid when meropenem (2 g every 8 h) was administered to Japanese adult patients with bacterial meningitis. Five Japanese patients (mean age 60.6 years [range 35–71]) were enrolled. Inf...
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| Veröffentlicht in: | Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy 2014-09, Vol.20 (9), p.535-540 |
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| creator | Morita, Akihiko Kamei, Satoshi Minami, Masayuki Yoshida, Kazuto Kawabata, Satoshi Kuroda, Hiroshi Suzuki, Yasushi Araki, Nobuo Iwasaki, Yasuo Kobayashi, Rei Hayashi, Naoki Hirayama, Tetsuyuki Ochiai, Jun Ueda, Miki Yamagishi, Yuka Niwa, Jun-ichi Shindo, Katsuro Fukushima, Yoshihisa Takita, Tomohiro Sato, Takayuki Sato, Shigeru Mikamo, Hiroshige Iwata, Satoshi |
| description | Abstract The aim of this study was to assess the efficacy, safety, and concentration of meropenem in cerebrospinal fluid when meropenem (2 g every 8 h) was administered to Japanese adult patients with bacterial meningitis. Five Japanese patients (mean age 60.6 years [range 35–71]) were enrolled. Infection with Streptococcus pneumoniae (three patients), Streptococcus salivarius (one patient), and Staphylococcus aureus (one patient) was confirmed by cerebrospinal fluid culture. Meropenem (2 g every 8 h) was administered to all five patients. Treatment duration ranged from 14 to 28 days (mean 22.6 days). All the patients were successfully treated. The concentration of meropenem in cerebrospinal fluid ranged from 0.27 to 6.40 μg/ml up to 8.47 h and was over 1 μg/ml 3 h after starting meropenem infusion. In each patient, the present study confirmed for the first time that the concentration of meropenem in cerebrospinal fluid exceeded the minimal inhibitory concentration for these pathogens. Eleven clinical and laboratory adverse events considered to be related to meropenem were observed in all patients, but no serious adverse event and no discontinuance of treatment due to adverse events occurred. Thus meropenem appeared to be a well-tolerated and effective agent for Japanese adult patients with bacterial meningitis. 2 g every 8 h of meropenem was delivered to CSF and its concentration was exceed in MICs for the detected pathogens. |
| doi_str_mv | 10.1016/j.jiac.2014.04.013 |
| format | Article |
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Five Japanese patients (mean age 60.6 years [range 35–71]) were enrolled. Infection with Streptococcus pneumoniae (three patients), Streptococcus salivarius (one patient), and Staphylococcus aureus (one patient) was confirmed by cerebrospinal fluid culture. Meropenem (2 g every 8 h) was administered to all five patients. Treatment duration ranged from 14 to 28 days (mean 22.6 days). All the patients were successfully treated. The concentration of meropenem in cerebrospinal fluid ranged from 0.27 to 6.40 μg/ml up to 8.47 h and was over 1 μg/ml 3 h after starting meropenem infusion. In each patient, the present study confirmed for the first time that the concentration of meropenem in cerebrospinal fluid exceeded the minimal inhibitory concentration for these pathogens. Eleven clinical and laboratory adverse events considered to be related to meropenem were observed in all patients, but no serious adverse event and no discontinuance of treatment due to adverse events occurred. Thus meropenem appeared to be a well-tolerated and effective agent for Japanese adult patients with bacterial meningitis. 2 g every 8 h of meropenem was delivered to CSF and its concentration was exceed in MICs for the detected pathogens.</description><identifier>ISSN: 1341-321X</identifier><identifier>EISSN: 1437-7780</identifier><identifier>DOI: 10.1016/j.jiac.2014.04.013</identifier><identifier>PMID: 24882451</identifier><language>eng</language><publisher>Netherlands: Elsevier Ltd</publisher><subject>Adult ; Aged ; Anti-Bacterial Agents - adverse effects ; Anti-Bacterial Agents - therapeutic use ; Bacterial meningitis ; Efficacy ; Female ; Hematology, Oncology and Palliative Medicine ; Humans ; Japan ; Japanese ; Male ; Meningitis, Bacterial - cerebrospinal fluid ; Meningitis, Bacterial - drug therapy ; Meningitis, Bacterial - microbiology ; Meropenem ; Microbial Sensitivity Tests ; Middle Aged ; Safety ; Staphylococcal Infections - cerebrospinal fluid ; Staphylococcal Infections - drug therapy ; Staphylococcal Infections - microbiology ; Staphylococcus - drug effects ; Thienamycins - adverse effects ; Thienamycins - therapeutic use ; Treatment Outcome</subject><ispartof>Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy, 2014-09, Vol.20 (9), p.535-540</ispartof><rights>Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases</rights><rights>2014 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases</rights><rights>Copyright © 2014 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c571t-ffbd6e07688793f243af34e390c55d3febf248e09ff4244fcdb90b71cdef5b173</citedby><cites>FETCH-LOGICAL-c571t-ffbd6e07688793f243af34e390c55d3febf248e09ff4244fcdb90b71cdef5b173</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24882451$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Morita, Akihiko</creatorcontrib><creatorcontrib>Kamei, Satoshi</creatorcontrib><creatorcontrib>Minami, Masayuki</creatorcontrib><creatorcontrib>Yoshida, Kazuto</creatorcontrib><creatorcontrib>Kawabata, Satoshi</creatorcontrib><creatorcontrib>Kuroda, Hiroshi</creatorcontrib><creatorcontrib>Suzuki, Yasushi</creatorcontrib><creatorcontrib>Araki, Nobuo</creatorcontrib><creatorcontrib>Iwasaki, Yasuo</creatorcontrib><creatorcontrib>Kobayashi, Rei</creatorcontrib><creatorcontrib>Hayashi, Naoki</creatorcontrib><creatorcontrib>Hirayama, Tetsuyuki</creatorcontrib><creatorcontrib>Ochiai, Jun</creatorcontrib><creatorcontrib>Ueda, Miki</creatorcontrib><creatorcontrib>Yamagishi, Yuka</creatorcontrib><creatorcontrib>Niwa, Jun-ichi</creatorcontrib><creatorcontrib>Shindo, Katsuro</creatorcontrib><creatorcontrib>Fukushima, Yoshihisa</creatorcontrib><creatorcontrib>Takita, Tomohiro</creatorcontrib><creatorcontrib>Sato, Takayuki</creatorcontrib><creatorcontrib>Sato, Shigeru</creatorcontrib><creatorcontrib>Mikamo, Hiroshige</creatorcontrib><creatorcontrib>Iwata, Satoshi</creatorcontrib><title>Open-label study to evaluate the pharmacodynamics, clinical efficacy, and safety of meropenem for adult bacterial meningitis in Japan</title><title>Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy</title><addtitle>J Infect Chemother</addtitle><description>Abstract The aim of this study was to assess the efficacy, safety, and concentration of meropenem in cerebrospinal fluid when meropenem (2 g every 8 h) was administered to Japanese adult patients with bacterial meningitis. Five Japanese patients (mean age 60.6 years [range 35–71]) were enrolled. Infection with Streptococcus pneumoniae (three patients), Streptococcus salivarius (one patient), and Staphylococcus aureus (one patient) was confirmed by cerebrospinal fluid culture. Meropenem (2 g every 8 h) was administered to all five patients. Treatment duration ranged from 14 to 28 days (mean 22.6 days). All the patients were successfully treated. The concentration of meropenem in cerebrospinal fluid ranged from 0.27 to 6.40 μg/ml up to 8.47 h and was over 1 μg/ml 3 h after starting meropenem infusion. In each patient, the present study confirmed for the first time that the concentration of meropenem in cerebrospinal fluid exceeded the minimal inhibitory concentration for these pathogens. Eleven clinical and laboratory adverse events considered to be related to meropenem were observed in all patients, but no serious adverse event and no discontinuance of treatment due to adverse events occurred. Thus meropenem appeared to be a well-tolerated and effective agent for Japanese adult patients with bacterial meningitis. 2 g every 8 h of meropenem was delivered to CSF and its concentration was exceed in MICs for the detected pathogens.</description><subject>Adult</subject><subject>Aged</subject><subject>Anti-Bacterial Agents - adverse effects</subject><subject>Anti-Bacterial Agents - therapeutic use</subject><subject>Bacterial meningitis</subject><subject>Efficacy</subject><subject>Female</subject><subject>Hematology, Oncology and Palliative Medicine</subject><subject>Humans</subject><subject>Japan</subject><subject>Japanese</subject><subject>Male</subject><subject>Meningitis, Bacterial - cerebrospinal fluid</subject><subject>Meningitis, Bacterial - drug therapy</subject><subject>Meningitis, Bacterial - microbiology</subject><subject>Meropenem</subject><subject>Microbial Sensitivity Tests</subject><subject>Middle Aged</subject><subject>Safety</subject><subject>Staphylococcal Infections - cerebrospinal fluid</subject><subject>Staphylococcal Infections - drug therapy</subject><subject>Staphylococcal Infections - microbiology</subject><subject>Staphylococcus - drug effects</subject><subject>Thienamycins - adverse effects</subject><subject>Thienamycins - therapeutic use</subject><subject>Treatment Outcome</subject><issn>1341-321X</issn><issn>1437-7780</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9ks-K1jAUxYsozh99AReSpYvpZ26Tfm1BBBmc0WFgFiq4C2ly46S2SU3SgT6A7z0p34wLFwMXbgjnHMjvpCjeAN0Bhf37YTdYqXYVBb6jeYA9K46Bs6ZsmpY-z2fGoWQV_DwqTmIcKIWmbtuXxVHF27biNRwXf29mdOUoexxJTIteSfIE7-S4yIQk3SKZb2WYpPJ6dXKyKp4RNVpnlRwJGpO3Ws-IdJpEaTCtxBsyYfA5FidifCBSL2MivVQJg82uCZ11v2yykVhHruQs3avihZFjxNcP-7T4cfH5-_mX8vrm8uv5p-tS1Q2k0phe75E2-7ZtOmYqzqRhHFlHVV1rZrDPdy3SzhhecW6U7jvaN6A0mrqHhp0W7w65c_B_FoxJTDYqHEfp0C9RQF3zjlPKIEurg1QFH2NAI-ZgJxlWAVRs-MUgNvxiwy9oHmDZ9PYhf-kn1P8sj7yz4MNBgPmVdxaDiMqiU6htQJWE9vbp_I__2R-7-I0rxsEvwWV-AkSsBBXftg-w9Q98676r2D3-Yq28</recordid><startdate>20140901</startdate><enddate>20140901</enddate><creator>Morita, Akihiko</creator><creator>Kamei, Satoshi</creator><creator>Minami, Masayuki</creator><creator>Yoshida, Kazuto</creator><creator>Kawabata, Satoshi</creator><creator>Kuroda, Hiroshi</creator><creator>Suzuki, Yasushi</creator><creator>Araki, Nobuo</creator><creator>Iwasaki, Yasuo</creator><creator>Kobayashi, Rei</creator><creator>Hayashi, Naoki</creator><creator>Hirayama, Tetsuyuki</creator><creator>Ochiai, Jun</creator><creator>Ueda, Miki</creator><creator>Yamagishi, Yuka</creator><creator>Niwa, Jun-ichi</creator><creator>Shindo, Katsuro</creator><creator>Fukushima, Yoshihisa</creator><creator>Takita, Tomohiro</creator><creator>Sato, Takayuki</creator><creator>Sato, Shigeru</creator><creator>Mikamo, Hiroshige</creator><creator>Iwata, Satoshi</creator><general>Elsevier Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20140901</creationdate><title>Open-label study to evaluate the pharmacodynamics, clinical efficacy, and safety of meropenem for adult bacterial meningitis in Japan</title><author>Morita, Akihiko ; 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Five Japanese patients (mean age 60.6 years [range 35–71]) were enrolled. Infection with Streptococcus pneumoniae (three patients), Streptococcus salivarius (one patient), and Staphylococcus aureus (one patient) was confirmed by cerebrospinal fluid culture. Meropenem (2 g every 8 h) was administered to all five patients. Treatment duration ranged from 14 to 28 days (mean 22.6 days). All the patients were successfully treated. The concentration of meropenem in cerebrospinal fluid ranged from 0.27 to 6.40 μg/ml up to 8.47 h and was over 1 μg/ml 3 h after starting meropenem infusion. In each patient, the present study confirmed for the first time that the concentration of meropenem in cerebrospinal fluid exceeded the minimal inhibitory concentration for these pathogens. Eleven clinical and laboratory adverse events considered to be related to meropenem were observed in all patients, but no serious adverse event and no discontinuance of treatment due to adverse events occurred. Thus meropenem appeared to be a well-tolerated and effective agent for Japanese adult patients with bacterial meningitis. 2 g every 8 h of meropenem was delivered to CSF and its concentration was exceed in MICs for the detected pathogens.</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>24882451</pmid><doi>10.1016/j.jiac.2014.04.013</doi><tpages>6</tpages></addata></record> |
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| ispartof | Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy, 2014-09, Vol.20 (9), p.535-540 |
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| subjects | Adult Aged Anti-Bacterial Agents - adverse effects Anti-Bacterial Agents - therapeutic use Bacterial meningitis Efficacy Female Hematology, Oncology and Palliative Medicine Humans Japan Japanese Male Meningitis, Bacterial - cerebrospinal fluid Meningitis, Bacterial - drug therapy Meningitis, Bacterial - microbiology Meropenem Microbial Sensitivity Tests Middle Aged Safety Staphylococcal Infections - cerebrospinal fluid Staphylococcal Infections - drug therapy Staphylococcal Infections - microbiology Staphylococcus - drug effects Thienamycins - adverse effects Thienamycins - therapeutic use Treatment Outcome |
| title | Open-label study to evaluate the pharmacodynamics, clinical efficacy, and safety of meropenem for adult bacterial meningitis in Japan |
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