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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.
. 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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolonged Infusion Group (PIG) | Experimental | 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) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meropenem Infusion | Drug | Inclusion Criteria:
Exclusion Criteria:
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical success rate by Day 7 | 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. | Day 1 to Day 7 of treatment |
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Inclusion Criteria:
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
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Nadia Iqbal, MBBS, FCPS PEADS | Pakistan Navy Station Shifa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pns Shifa Hospital, Karachi. | Karachi | Sindh | 75530 | Pakistan |
Individual participant data (IPD) will not be shared due to institutional policies and ethical considerations regarding patient confidentiality. Access to patient-level data is restricted to the study team to ensure data privacy and compliance with local regulations.
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D001424 | Bacterial Infections |
| D007239 | Infections |
| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Participants are randomly assigned to receive either prolonged infusion or standard infusion of meropenem to compare efficacy in critically ill pediatric patients.
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| D001423 | Bacterial Infections and Mycoses |