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

NCT ID: NCT07122596

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2024-08-31

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.

Conditions

Sepsis; Bacterial Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Meropenem Infusion

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Meropenem Infusion

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pakistan Navy Station Shifa Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nadia Iqbal

POSTGRADUATE TRAINEE

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nadia Iqbal, MBBS, FCPS PEADS

Role: PRINCIPAL_INVESTIGATOR

Pakistan Navy Station Shifa Hospital

Locations

Pns Shifa Hospital, Karachi.

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

PNS-PG -2024-001 to 2024-150

Identifier Type: -

Identifier Source: org_study_id