Sepsis, Bacterial Infection
Conditions
Keywords
INFECTION, SEPSIS, BACTERIA, BACTERIAL, INTENSIVE CARE, PICU, PAEDIATRIC ICU, ICU, MEROPENEM, PROLONGED INFUSION, STANDARD INFUSION, EXTENDED
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.
Interventions
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
Pakistan Navy Station Shifa Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are randomly assigned to receive either prolonged infusion or standard infusion of meropenem to compare efficacy in critically ill pediatric patients.
Eligibility
Sex/Gender
ALL
Age
1 Months to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success rate by Day 7 | 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. |
Countries
Pakistan
Outcome results
None listed