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

NCT07122596 | Completed Phase 4 DMC

• 1 other identifier: PNS-PG -2024-001 to 2024-150
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Bacterial Infection

Keywords

INFECTION; SEPSIS; BACTERIA; BACTERIAL; INTENSIVE CARE; PICU; PAEDIATRIC ICU; ICU; MEROPENEM; PROLONGED INFUSION; STANDARD INFUSION; EXTENDED

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Drug: Meropenem Infusion

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.

Drug: Meropenem Infusion

Interventions

Meropenem Infusion DRUG

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

Prolonged Infusion Group (PIG); Standard Infusion Group (SIG)

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pakistan Navy Station Shifa Hospital: lead

Study Sites (1)

Pns Shifa Hospital, Karachi.

Karachi, Sindh, 75530, Pakistan

Location

MeSH Terms

Conditions

Sepsis; Bacterial Infections; Infections

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses

Study Officials

• Nadia Iqbal, MBBS, FCPS PEADS

  Pakistan Navy Station Shifa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: POSTGRADUATE TRAINEE

Model Details: Participants are randomly assigned to receive either prolonged infusion or standard infusion of meropenem to compare efficacy in critically ill pediatric patients.

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 14, 2025
• Study Start: April 1, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)