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

Affiliation
Laboratory of Respiratory Diseases, Beijing Key Laboratory of Pediatric Respiratory Infection Diseases, Beijing Pediatric Research Institute, Beijing Children’s Hospital, Capital Medical University, Key Laboratory of Major Diseases in Children, Ministry of Education, National Clinical Research Center for Respiratory Diseases, National Center for Children’s Health ,Beijing ,China
Tian, Xue;
Affiliation
Department of Pharmacy ,Children’s Hospital of Hebei Province ,Shijiazhuang ,Hebei ,China
Dong, Lei;
Affiliation
Baoding Key Laboratory of Precision Diagnosis and Treatment of Children Infectious Diseases ,Baoding Children’s Hospital ,Baoding ,Hebei ,China
Jiang, Ting-Ting;
Affiliation
Key Laboratory of Chemical Biology ,Ministry of Education ,Department of Clinical Pharmacy ,School of Pharmaceutical Sciences ,Cheeloo College of Medicine ,Shandong University ,Jinan ,China
Tang, Bo-Hao;
Affiliation
Department of Pediatrics ,Beijing Friendship Hospital ,Capital Medical University ,Beijing ,China
Wang, Ze-Ming;
Affiliation
Key Laboratory of Chemical Biology ,Ministry of Education ,Department of Clinical Pharmacy ,School of Pharmaceutical Sciences ,Cheeloo College of Medicine ,Shandong University ,Jinan ,China
Wu, Yue-E;
Affiliation
Pediatric Research Institute ,Children’s Hospital of Hebei Province ,Shijiazhuang ,Hebei ,China
You, Dian-Ping;
Affiliation
Baoding Key Laboratory of Precision Diagnosis and Treatment of Children Infectious Diseases ,Baoding Children’s Hospital ,Baoding ,Hebei ,China
Bi, Jing;
Affiliation
Pediatric Intensive Care Unit ,Beijing Children’s Hospital ,National Center for Children’s Health ,Capital Medical University ,Beijing ,China
Qian, Su-Yun;
Affiliation
Laboratory of Respiratory Diseases, Beijing Key Laboratory of Pediatric Respiratory Infection Diseases, Beijing Pediatric Research Institute, Beijing Children’s Hospital, Capital Medical University, Key Laboratory of Major Diseases in Children, Ministry of Education, National Clinical Research Center for Respiratory Diseases, National Center for Children’s Health ,Beijing ,China
Qi, Hui;
Affiliation
Laboratory of Respiratory Diseases, Beijing Key Laboratory of Pediatric Respiratory Infection Diseases, Beijing Pediatric Research Institute, Beijing Children’s Hospital, Capital Medical University, Key Laboratory of Major Diseases in Children, Ministry of Education, National Clinical Research Center for Respiratory Diseases, National Center for Children’s Health ,Beijing ,China
Shen, A-Dong

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. Clinical Trial Registration : http://www.chictr.org.cn identifier, ChiCTR2200061207.

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License Holder: Copyright © 2022 Tian, Dong, Jiang, Tang, Wang, Wu, You, Bi, Qian, Qi and Shen.

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