EFFICACY OF PROLONGED INFUSION MEROPENEM IN CRITICALLY ILL PAEDIATRIC INTENSIVE CARE PATIENTS
- Registration Number
- NCT07122596
- Lead Sponsor
- Pakistan Navy Station Shifa Hospital
- Brief Summary
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.
- Detailed Description
. 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).
Secondary Objectives:
* To compare the clinical success rate between prolonged infusion and standard infusion of meropenem.
* To assess the infection clearance rate in patients receiving prolonged infusion versus standard infusion of meropenem.
* To determine the time to clinical improvement in critically ill pediatric patients treated with prolonged infusion compared to standard infusion.
* To evaluate the safety and tolerability of prolonged infusion meropenem in the PICU setting.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prolonged Infusion Group (PIG) Meropenem Infusion 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. Standard Infusion Group (SIG) Meropenem Infusion 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.
- Primary Outcome Measures
Name Time Method Clinical success rate by Day 7 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pns Shifa Hospital, Karachi.
🇵🇰Karachi, Sindh, Pakistan
Pns Shifa Hospital, Karachi.🇵🇰Karachi, Sindh, Pakistan