SepsisPhase 4NCT07122596
EFFICACY OF PROLONGED INFUSION MEROPENEM IN CRITICALLY ILL PAEDIATRIC INTENSIVE CARE PATIENTS
A Phase 4 study testing Meropenem Infusion in people with Sepsis and Bacterial Infection, run by Pakistan Navy Station Shifa Hospital at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Sepsis, Bacterial Infection
- What is being tested?
- Meropenem Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2024to 31 Aug 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Meropenem Infusion
- Keywords
- INFECTION, SEPSIS, BACTERIA, BACTERIAL, INTENSIVE CARE, PICU, PAEDIATRIC ICU, ICU, MEROPENEM, PROLONGED INFUSION, STANDARD INFUSION, EXTENDED
- Medical subject headings
- Sepsis, Bacterial Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meropenem InfusionDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Meropenem Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 to Day 7 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 Apr 2024
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to receive either prolonged infusion or standard infusion of meropenem to compare efficacy in critically ill pediatric patients.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Navy Station Shifa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadia Iqbal, Pakistan Navy Station Shifa Hospital
- Investigators
- Nadia Iqbal, MBBS, FCPS PEADS, Principal investigator, Pakistan Navy Station Shifa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122596
- Sponsor's protocol ID
- PNS-PG -2024-001 to 2024-150
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to institutional policies and ethical considerations regarding patient confidentiality. Access to patient-level data is restricted to the study team to ensure data privacy and compliance with local regulations.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFICACY OF PROLONGED INFUSION MEROPENEM IN CRITICALLY ILL PAEDIATRIC INTENSIVE CARE PATIENTS
- ClinicalTrials.gov ID
- NCT07122596
- Acronym / sponsor ID
- PNS-PG -2024-001 to 2024-150
- Conditions
- Sepsis, Bacterial Infection
- Keywords
- INFECTION, SEPSIS, BACTERIA, BACTERIAL, INTENSIVE CARE, PICU, PAEDIATRIC ICU, ICU
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Pakistan Navy Station Shifa HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to receive either prolonged infusion or standard infusion of meropenem to compare efficacy in critically ill pediatric patients.
| Arm | Type | Receives |
|---|---|---|
| Prolonged Infusion Group (PIG) | Experimental | Drug: Meropenem InfusionDrug: 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. |
| Standard Infusion Group (SIG) | Active comparator | Drug: Meropenem InfusionDrug: 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. |
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meropenem InfusionInclusion 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 | Drug | Prolonged Infusion Group (PIG), Standard Infusion Group (SIG) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to institutional policies and ethical considerations regarding patient confidentiality. Access to patient-level data is restricted to the study team to ensure data privacy and compliance with local regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadia Iqbal, MBBS, FCPS PEADS principal investigator
Pakistan Navy Station Shifa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Meropenem Infusion in people with Sepsis and Bacterial Infection, run by Pakistan Navy Station Shifa Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success rate by Day 7 (time frame: Day 1 to Day 7 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.