EFFICACY OF PROLONGED INFUSION MEROPENEM IN CRITICALLY ILL PAEDIATRIC INTENSIVE CARE PATIENTS
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Clinical success rate by Day 7
研究概览
简要总结
As a broad-spectrum carbapenem, meropenem is one of the most commonly used antibiotics for critically ill pediatric patients who have severe infections. The time-dependent bactericidal activity of is consistent with the possibility that this bactericidal activity can be optimized by continuous or prolonged infusion of the drug, which would keep the drug concentration above the MIC for longer. Despite the increasing use in adult critically ill patients, the use of this process is not widely utilized in pediatric ICUs (PICUs).
With the growing concern of antimicrobial resistance, especially in children, the need for well-demonstrated dosing strategies for antimicrobials has never been more critical. Extended infusions of meropenem may provide better therapeutic effects in children by using the maximum amount of drug exposure, as well as less selection of resistance. This trial was conducted to compare the efficacy of prolonged infusion of meropenem in the critically ill visiting pediatric population, aimed at generating evidence for dosing approach in PICU.
详细描述
. Background and Rationale As a broad-spectrum carbapenem, meropenem is one of the most commonly used antibiotics for critically ill pediatric patients who have severe infections. The time-dependent bactericidal activity of is consistent with the possibility that this bactericidal activity can be optimized by continuous or prolonged infusion of the drug, which would keep the drug concentration above the MIC for longer. Despite the increasing use in adult critically ill patients, the use of this process is not widely utilized in pediatric ICUs (PICUs).
With the growing concern of antimicrobial resistance, especially in children, the need for well-demonstrated dosing strategies for antimicrobials has never been more critical. Extended infusions of meropenem may provide better therapeutic effects in children by using the maximum amount of drug exposure, as well as less selection of resistance. This trial was conducted to compare the efficacy of prolonged infusion of meropenem in the critically ill visiting pediatric population, aimed at generating evidence for dosing approach in PICU.
Objectives
Primary Objective:
• To evaluate the efficacy of prolonged infusion meropenem in comparison to standard infusion in critically ill pediatric patients admitted to the Pediatric Intensive Care Unit (PICU).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 1 month and 16 years
- •Admitted to the Pediatric Intensive Care Unit (PICU) with suspected or confirmed bacterial infection
- •Prescribed intravenous meropenem
- •Informed written consent obtained from parent or legal guardian
排除标准
- •Known allergy or hypersensitivity to carbapenem antibiotics
- •Severe renal impairment (eGFR < 30 mL/min/1.73 m²)
- •Concurrent use of other investigational antibiotics
- •Treatment terminated early or patient discharged against medical advice
研究组 & 干预措施
Prolonged Infusion Group (PIG)
Drug: Meropenem (Prolonged Infusion)
Dose: As per body weight and infection severity, following standard pediatric dosing guidelines
Frequency: Every 8 hours (three times daily)
Route: Intravenous (IV) infusion
Duration: 7 days
Other Names: Meropenem prolonged infusion
Arm Description:
Participants receive meropenem administered as a prolonged intravenous infusion over an extended period, instead of standard infusion duration.
干预措施: Meropenem Infusion (Drug)
Standard Infusion Group (SIG)
Drug: Meropenem (Standard Infusion) Dose: As per body weight and infection severity, following standard pediatric dosing guidelines Frequency: Every 8 hours (three times daily) Route: Intravenous (IV) infusion Duration: 7 days Other Names: Meropenem standard infusion
Arm Description:
Participants receive meropenem administered via standard intravenous infusion duration as per usual hospital protocol.
干预措施: Meropenem Infusion (Drug)
结局指标
主要结局
Clinical success rate by Day 7
时间窗: Day 1 to Day 7 of treatment
Defined as complete resolution of infection-related signs and symptoms, normalization of laboratory values (e.g., WBC count, CRP), and clinical stability in critically ill pediatric patients receiving either prolonged or standard meropenem infusion.
次要结局
未报告次要终点
研究者
Nadia Iqbal
POSTGRADUATE TRAINEE
Pakistan Navy Station Shifa Hospital