NCT07122596

EFFICACY OF PROLONGED INFUSION MEROPENEM IN CRITICALLY ILL PAEDIATRIC INTENSIVE CARE PATIENTS

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Pakistan Navy Station Shifa Hospital · Academic / Other
• Sex: All
• Age: 1 Month – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis
• Bacterial Infection

Interventions

Type	Name	Description
DRUG	Meropenem Infusion	Inclusion Criteria: * 1 month to 16 years old * Bacterial Infection (suspected or known) Admitted to PICU with suspected or known bacterial infection * Prescribed intravenous meropenem * Informed consent obtained from parent/guardian Exclusion Criteria: * Known allergy to carbapenems * Severe renal impairment (eGFR \< 30 mL/min/1.73 m²) * Use of other investigational antibiotics at the same time * Prematurely Terminating the Treatment or Early Discharge Against Medical Advice Age Range: 1 month to 16 years old Gender: BOTH Sample Size (Number of participants): 150

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2025-08-14
• Last updated: 2025-08-14

Locations

1 site across 1 country: Pakistan