Meropenem for children with severe pneumonia: Protocol for a randomized controlled trial
Xue Tian1, Lei Dong2, Ting-Ting Jiang3
1Laboratory 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.
Insights
This study compares conventional versus model-based meropenem dosing for pediatric severe pneumonia. The model-based regimen aims to optimize meropenem exposure, potentially improving treatment outcomes in children.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacokinetics and Pharmacodynamics
- Clinical Trial Design
Background:
- Pneumonia poses a significant health risk to children.
- Meropenem is a vital broad-spectrum antibiotic for severe infections.
- Previous population pharmacokinetic modeling informed optimized meropenem dosing strategies.
Purpose of the Study:
- To compare the efficacy and safety of a model-guided meropenem regimen against conventional dosing in pediatric severe pneumonia.
- To evaluate the achievement of target pharmacokinetic/pharmacodynamic (PK/PD) goals, specifically 70% time above minimum inhibitory concentration (MIC).
Main Methods:
- A multicenter randomized controlled trial involving 100 pediatric patients (3 months to 15 years).
- Patients randomized to conventional (20 mg/kg, q8h, 0.5-1h infusion) or model-guided (20 mg/kg, q8h, 4h infusion) meropenem therapy.
- Primary endpoint: 70% free plasma concentration above MIC (70% fT > MIC). Secondary endpoints include treatment failure, duration of therapy, inflammatory markers, and adverse events.
Main Results:
- The study is designed to assess the primary outcome of 70% fT > MIC.
- Secondary outcomes will evaluate clinical and microbiological treatment success, safety, and inflammatory markers.
- Results will guide optimized meropenem dosing for severe pediatric pneumonia.
Conclusions:
- This randomized controlled trial aims to validate a model-based meropenem dosing strategy for severe pediatric pneumonia.
- The findings are expected to support the rational use of antibiotics in critically ill children.
- Optimized dosing may improve therapeutic efficacy and patient outcomes.
Abstract:
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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