EFFICACY OF PROLONGED INFUSION MEROPENEM IN CRITICALLY ILL PAEDIATRIC INTENSIVE CARE PATIENTS
NCT07122596 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2025-08-14
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
Interventions
- 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
Sponsors & Collaborators
-
Pakistan Navy Station Shifa Hospital
lead OTHER
Principal Investigators
-
Nadia Iqbal, MBBS, FCPS PEADS · Pakistan Navy Station Shifa Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 1 Month
- Max Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-01
- Primary Completion
- 2024-08-31
- Completion
- 2024-08-31
Countries
- Pakistan
Study Locations
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