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Completed

NCT Number: NCT07122596

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

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.

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Key information

Age range

1 month–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pns Shifa Hospital, Karachi.

Karachi, Sindh, 75530, Pakistan

About this study

. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Clinical success rate by Day 7

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pakistan Navy Station Shifa Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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