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Meropenem for children with severe pneumonia: Protocol for a randomized controlled trial

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单位: [1]Capital Med Univ, Natl Ctr Childrens Hlth, Key Lab Major Dis Children, Lab Resp Dis,Beijing Key Lab Pediat Resp Infect Di, Beijing, Peoples R China [2]Childrens Hosp Hebei Prov, Dept Pharm, Shijiazhuang, Hebei, Peoples R China [3]Baoding Childrens Hosp, Baoding Key Lab Precis Diag & Treatment Children I, Baoding, Hebei, Peoples R China [4]Capital Med Univ, Beijing Friendship Hosp, Dept Pediat, Beijing, Peoples R China [5]Shandong Univ, Cheeloo Coll Med, Sch Pharmaceut Sci, Dept Clin Pharm, Jinan, Peoples R China [6]Childrens Hosp Hebei Prov, Pediat Res Inst, Shijiazhuang, Hebei, Peoples R China [7]Capital Med Univ, Beijing Childrens Hosp, Natl Ctr Childrens Hlth, Pediat Intens Care Unit, Beijing, Peoples R China
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关键词: meropenem severe pneumonia children randomized controlled trial study protocol

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Background: Pneumonia, caused by infection or other factors, seriously endangers the health of children. Meropenem is an effective broad-spectrum antibiotic using in the treatment of infectious diseases. In the therapy of pneumonia, meropenem is mostly employed for the treatment of moderate to severe pneumonia. Previously, we established a population pharmacokinetics (PPK) model for meropenem in pediatric severe infection and simulated the control rate of the time during which the free plasma concentration of meropenem exceeds the minimum inhibitory concentration (MIC) is 70% of the dosing interval (70% fT > MIC). Therefore, we plan to conduct a multicenter randomized controlled trial (RCT) to compare the efficacy and safety between conventional regimen and model regimen for meropenem in pediatric severe pneumonia. Methods: One hundred patients (aged 3 months to 15 years) will be recruited in this RCT. They will be assigned randomly (at a 1:1 ratio) to a conventional treatment group (20 mg/kg, q8h, with 0.5-1 h infusion) and a model treatment group (20 mg/kg, q8 h, with 4 h infusion). The primary outcome will be 70% fT > MIC. Secondary outcomes will be the prevalence of meropenem therapy failure, duration of antibiotic therapy, changes in levels of inflammatory indicators, changes in imaging examination results, and prevalence of adverse events. Ethical approval of our clinical trial has been granted by the ethics committee of Beijing Children's Hospital ([2022]-E-133-Y). This trial has been registered in the Chinese Clinical Trial Registry (ChiCTR2200061207). Discussion: Based on our previous PPK data, we have designed this RCT. It is hoped that it will promote rational use of antibacterial drugs in children suffering from severe pneumonia.

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出版当年[2021]版:
大类 | 2 区 医学
小类 | 2 区 药学
最新[2025]版:
大类 | 3 区 医学
小类 | 3 区 药学
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出版当年[2020]版:
Q1 PHARMACOLOGY & PHARMACY
最新[2023]版:
Q1 PHARMACOLOGY & PHARMACY

影响因子: 最新[2023版] 最新五年平均[2021-2025] 出版当年[2020版] 出版当年五年平均[2016-2020] 出版前一年[2019版] 出版后一年[2021版]

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第一作者单位: [1]Capital Med Univ, Natl Ctr Childrens Hlth, Key Lab Major Dis Children, Lab Resp Dis,Beijing Key Lab Pediat Resp Infect Di, Beijing, Peoples R China
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通讯机构: [1]Capital Med Univ, Natl Ctr Childrens Hlth, Key Lab Major Dis Children, Lab Resp Dis,Beijing Key Lab Pediat Resp Infect Di, Beijing, Peoples R China [3]Baoding Childrens Hosp, Baoding Key Lab Precis Diag & Treatment Children I, Baoding, Hebei, Peoples R China
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