A Multicenter Randomized Controlled Study on Pharmacokinetic‐Guided Vancomycin Use in Children With Severe Infections
ABSTRACT This study is a multicenter, randomized controlled prospective trial aimed at evaluating the effects of two vancomycin pharmacokinetics/pharmacodynamics (PK/PD) parameters on clinical outcomes in children with different severe infections: trough concentration (Cmin) and the area under the c...
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Wiley
2025-08-01
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| Series: | Clinical and Translational Science |
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| Online Access: | https://doi.org/10.1111/cts.70309 |
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| author | Fuxiang He Ya Yang Bo Zhou Chengcheng Li Yu Feng Xuexin Wang Haifeng Liu Yuhang Hu Hongmin Fu Yingbo Zou Guoying Zhang Jianli Chen Yueqiang Fu Shufang Xiao Lan Hu Chengjun Liu |
| author_facet | Fuxiang He Ya Yang Bo Zhou Chengcheng Li Yu Feng Xuexin Wang Haifeng Liu Yuhang Hu Hongmin Fu Yingbo Zou Guoying Zhang Jianli Chen Yueqiang Fu Shufang Xiao Lan Hu Chengjun Liu |
| author_sort | Fuxiang He |
| collection | DOAJ |
| description | ABSTRACT This study is a multicenter, randomized controlled prospective trial aimed at evaluating the effects of two vancomycin pharmacokinetics/pharmacodynamics (PK/PD) parameters on clinical outcomes in children with different severe infections: trough concentration (Cmin) and the area under the curve (AUC0‐24/MIC). From January 2023 to December 2024, 472 pediatric patients from seven hospitals in Southwest China were included in the present study. These patients were randomly assigned to the AUC0‐24/MIC group or the Cmin group. After excluding 75 patients with renal function impairment caused by the primary disease, three patients with incomplete data, and one patient who received vancomycin for less than 48 h, 393 patients were finally enrolled for the present study. Then, the vancomycin treatment for children was evaluated using two PK/PD parameters, to guide clinical efficacy and monitor the incidence of adverse reactions: AUC0‐24/MIC, with a target value of 400–600 mg·h/L; trough concentration (Cmin), with a target value of 5–15 mg/L. The results indicated that there were no significant differences between the two groups in terms of daily dose, clinical efficacy, and adverse reactions. However, patients in the Cmin group had significantly shorter pediatric intensive care unit (PICU) stays (Z = −2.05, p = 0.04), and patients in the 28‐day to 1‐year‐old subgroup had shorter mechanical ventilation times (Z = −2.25, p = 0.024). Both Cmin and AUC0‐24/MIC were effective in guiding the vancomycin treatment for children with severe infections. However, patients in the Cmin group presented with advantages in PICU stay and ventilation duration. Trial Registration: China Clinical Trial Registry: ChiCTR2300067373 |
| format | Article |
| id | doaj-art-dca93192826c4d2fb77b495e149fbcea |
| institution | Kabale University |
| issn | 1752-8054 1752-8062 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | Wiley |
| record_format | Article |
| series | Clinical and Translational Science |
| spelling | doaj-art-dca93192826c4d2fb77b495e149fbcea2025-08-23T17:10:42ZengWileyClinical and Translational Science1752-80541752-80622025-08-01188n/an/a10.1111/cts.70309A Multicenter Randomized Controlled Study on Pharmacokinetic‐Guided Vancomycin Use in Children With Severe InfectionsFuxiang He0Ya Yang1Bo Zhou2Chengcheng Li3Yu Feng4Xuexin Wang5Haifeng Liu6Yuhang Hu7Hongmin Fu8Yingbo Zou9Guoying Zhang10Jianli Chen11Yueqiang Fu12Shufang Xiao13Lan Hu14Chengjun Liu15Department of Emergency Children's Hospital of Chongqing Medical University National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing Key Laboratory of Child Rare Diseases in Infection and Immunity Chongqing ChinaKunming Children's Hospital Kunming ChinaDepartment of Pharmacy Children's Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing Key Laboratory of Child Rare Diseases in Infection and Immunity Chongqing ChinaZunyi First People's Hospital, The Third Affiliated Hospital of Zunyi Medical University Zunyi ChinaChengdu Women and Children's Central Hospital Chengdu ChinaGuiyang Maternal and Child Health Care Hospital Guiyang Guizhou ChinaKunming Children's Hospital Kunming ChinaSichuan Maternal and Child Health Care Hospital, Sichuan Women and Children's Hospital Chengdu ChinaKunming Children's Hospital Kunming ChinaZunyi First People's Hospital, The Third Affiliated Hospital of Zunyi Medical University Zunyi ChinaChengdu Women and Children's Central Hospital Chengdu ChinaGuiyang Maternal and Child Health Care Hospital Guiyang Guizhou ChinaDepartment of Critical Care Unit Children's Hospital Affiliated to Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing Key Laboratory of Child Rare Diseases in Infection and Immunity Chongqing ChinaKunming Children's Hospital Kunming ChinaDepartment of Critical Care Unit Children's Hospital Affiliated to Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing Key Laboratory of Child Rare Diseases in Infection and Immunity Chongqing ChinaDepartment of Critical Care Unit Children's Hospital Affiliated to Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing Key Laboratory of Child Rare Diseases in Infection and Immunity Chongqing ChinaABSTRACT This study is a multicenter, randomized controlled prospective trial aimed at evaluating the effects of two vancomycin pharmacokinetics/pharmacodynamics (PK/PD) parameters on clinical outcomes in children with different severe infections: trough concentration (Cmin) and the area under the curve (AUC0‐24/MIC). From January 2023 to December 2024, 472 pediatric patients from seven hospitals in Southwest China were included in the present study. These patients were randomly assigned to the AUC0‐24/MIC group or the Cmin group. After excluding 75 patients with renal function impairment caused by the primary disease, three patients with incomplete data, and one patient who received vancomycin for less than 48 h, 393 patients were finally enrolled for the present study. Then, the vancomycin treatment for children was evaluated using two PK/PD parameters, to guide clinical efficacy and monitor the incidence of adverse reactions: AUC0‐24/MIC, with a target value of 400–600 mg·h/L; trough concentration (Cmin), with a target value of 5–15 mg/L. The results indicated that there were no significant differences between the two groups in terms of daily dose, clinical efficacy, and adverse reactions. However, patients in the Cmin group had significantly shorter pediatric intensive care unit (PICU) stays (Z = −2.05, p = 0.04), and patients in the 28‐day to 1‐year‐old subgroup had shorter mechanical ventilation times (Z = −2.25, p = 0.024). Both Cmin and AUC0‐24/MIC were effective in guiding the vancomycin treatment for children with severe infections. However, patients in the Cmin group presented with advantages in PICU stay and ventilation duration. Trial Registration: China Clinical Trial Registry: ChiCTR2300067373https://doi.org/10.1111/cts.70309age groupsclinical efficacyinfectionspediatricspharmacokineticsvancomycin |
| spellingShingle | Fuxiang He Ya Yang Bo Zhou Chengcheng Li Yu Feng Xuexin Wang Haifeng Liu Yuhang Hu Hongmin Fu Yingbo Zou Guoying Zhang Jianli Chen Yueqiang Fu Shufang Xiao Lan Hu Chengjun Liu A Multicenter Randomized Controlled Study on Pharmacokinetic‐Guided Vancomycin Use in Children With Severe Infections Clinical and Translational Science age groups clinical efficacy infections pediatrics pharmacokinetics vancomycin |
| title | A Multicenter Randomized Controlled Study on Pharmacokinetic‐Guided Vancomycin Use in Children With Severe Infections |
| title_full | A Multicenter Randomized Controlled Study on Pharmacokinetic‐Guided Vancomycin Use in Children With Severe Infections |
| title_fullStr | A Multicenter Randomized Controlled Study on Pharmacokinetic‐Guided Vancomycin Use in Children With Severe Infections |
| title_full_unstemmed | A Multicenter Randomized Controlled Study on Pharmacokinetic‐Guided Vancomycin Use in Children With Severe Infections |
| title_short | A Multicenter Randomized Controlled Study on Pharmacokinetic‐Guided Vancomycin Use in Children With Severe Infections |
| title_sort | multicenter randomized controlled study on pharmacokinetic guided vancomycin use in children with severe infections |
| topic | age groups clinical efficacy infections pediatrics pharmacokinetics vancomycin |
| url | https://doi.org/10.1111/cts.70309 |
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