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Bolus Versus Prolonged Infusion of Meropenem in Newborn With Late Onset Sepsis (BVPIMNBLOS)

Primary Purpose

Late Onset Neonatal Sepsis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Meropenem.
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Late Onset Neonatal Sepsis focused on measuring meropenem, infusion, late-onset sepsis, newborn, management

Eligibility Criteria

3 Days - 4 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Neonates admitted to the neonatal care unit (NCU) who suffer from late onset sepsis (LOS) at admission or during their NICU stay and receive meropenem for at least four days

Exclusion Criteria:

  • Acute or chronic renal failure
  • Hypersensitivity or allergy to meropenem

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Infusion arm

    Bolus group

    Arm Description

    Infants will receive a loading dose of 20 mg/kg/dose every 8 hours for sepsis and 40 mg/kg/dose every 8 hours in meningitis and pseudomonas infection. Each dose will be infused over four hours.

    Infants will receive a loading dose of 20 mg/kg/dose every 8 hours for sepsis and 40 mg/kg/dose every 8 hours in meningitis and pseudomonas infection. Each dose will be infused over thirty minutes.

    Outcomes

    Primary Outcome Measures

    Clinical outcome
    Success is defined as complete or partial resolution of leukocytosis, temperature, and clinical signs and symptoms of infection. Failure consists of persistence or progression of signs and symptoms of infection, development of new clinical findings consistent with active infection, or death from infection.
    Microbiological outcome
    Success is defined as eradication of infection or colonization which means detection of a new pathogen from the site of infection during meropenem therapy and no new antibiotic is indicated Failure is defined as persistence of infection and superinfection which means detection of a new pathogen from the site of infection during meropenem therapy and new antibiotic is indicated.

    Secondary Outcome Measures

    Meropenem-related length of mechanical ventilation
    The number of mechanical ventilation days from the start of meropenem administration
    Meropenem-related length of NICU stay
    The number of days from the beginning of meropenem therapy to discharge from NICU
    NICU mortality
    Death before discharge
    Duration of meropenem treatment
    Total days of meropenem treatment
    Clinical side effects of meropenem treatment
    Safety of meropenem therapy will be evaluated by clinical symptoms (diarrhea, rash, vomiting and seizures).
    Laboratory derangement related to meropenem treatment
    Assessment of laboratory parameters and their changes during meropenem therapy (transaminases, alkaline phosphatase, bilirubin).

    Full Information

    First Posted
    June 9, 2015
    Last Updated
    July 17, 2015
    Sponsor
    Mansoura University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02503761
    Brief Title
    Bolus Versus Prolonged Infusion of Meropenem in Newborn With Late Onset Sepsis
    Acronym
    BVPIMNBLOS
    Official Title
    Bolus Versus Prolonged Infusion of Meropenem in Newborn With Late Onset Sepsis: A Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2013 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mansoura University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Newborns in the neonatal intensive care unit (NICU), especially premature ones with immature organ systems, frequently suffer nosocomial infections caused by microorganisms resistant to narrow-spectrum antibiotics like ampicillin and gentamicin and require introduction of new agents with a wider spectrum of activity. Meropenem has activity against wide variety of Gram-negative and Gram-positive bacteria. It is well tolerated by children and neonates, including preterm babies, and allowing monotherapy instead of combined therapy. Severe neonatal infections with increasing antibiotic resistance are major problems affecting morbidity and mortality in the NICU. Few number of new antibacterial agents entering the clinic and new agents for multi-drug resistant Gram-negative bacteria will unlikely be available in the near future.
    Detailed Description
    More research into existing antibiotics with novel mechanisms of action are required to combat the increased resistance and decreased development of antibiotics. Efforts were exerted to maximize antibiotic efficacy by optimal dosing based on pharmacodynamic and pharmacokinetic properties of antibiotics. Meropenem is administered mostly via a 30-min infusion, as some data indicate rapid degradation after reconstitution. Dose recommendations from two pediatric studies using Monte Carlo simulation have emphasized that a 4-h infusion may be needed if microorganisms showed increased minimal inhibitory concentrations (MICs), more specifically, for Pseudomonas aeruginosa. A prolonged-infusion strategy has not been tested in neonates, although some data suggest that extremely small infusion volumes may significantly affect the drug amount actually delivered. Aim of work: The objective of our study is to compare the clinical and bacteriological efficacy of conventional intermittent dosing of meropenem to the prolonged infusions in critically-ill neonates, with a proactive focus on reducing ventilator days in ventilated patients, length of stay in NICU, and neonatal mortality.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Late Onset Neonatal Sepsis
    Keywords
    meropenem, infusion, late-onset sepsis, newborn, management

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Infusion arm
    Arm Type
    Active Comparator
    Arm Description
    Infants will receive a loading dose of 20 mg/kg/dose every 8 hours for sepsis and 40 mg/kg/dose every 8 hours in meningitis and pseudomonas infection. Each dose will be infused over four hours.
    Arm Title
    Bolus group
    Arm Type
    Active Comparator
    Arm Description
    Infants will receive a loading dose of 20 mg/kg/dose every 8 hours for sepsis and 40 mg/kg/dose every 8 hours in meningitis and pseudomonas infection. Each dose will be infused over thirty minutes.
    Intervention Type
    Drug
    Intervention Name(s)
    Meropenem.
    Intervention Description
    Infants in both groups will receive a loading dose of 20 mg/kg/dose every 8 hours for sepsis and 40 mg/kg/dose every 8 hours in meningitis and pseudomonas infection
    Primary Outcome Measure Information:
    Title
    Clinical outcome
    Description
    Success is defined as complete or partial resolution of leukocytosis, temperature, and clinical signs and symptoms of infection. Failure consists of persistence or progression of signs and symptoms of infection, development of new clinical findings consistent with active infection, or death from infection.
    Time Frame
    15-28 days from Meropenem treatment
    Title
    Microbiological outcome
    Description
    Success is defined as eradication of infection or colonization which means detection of a new pathogen from the site of infection during meropenem therapy and no new antibiotic is indicated Failure is defined as persistence of infection and superinfection which means detection of a new pathogen from the site of infection during meropenem therapy and new antibiotic is indicated.
    Time Frame
    7-21 days from Meropenem treatment
    Secondary Outcome Measure Information:
    Title
    Meropenem-related length of mechanical ventilation
    Description
    The number of mechanical ventilation days from the start of meropenem administration
    Time Frame
    0-31 days from Meropenem treatment
    Title
    Meropenem-related length of NICU stay
    Description
    The number of days from the beginning of meropenem therapy to discharge from NICU
    Time Frame
    10 weeks from Meropenem treatment
    Title
    NICU mortality
    Description
    Death before discharge
    Time Frame
    12 weeks from time of admission
    Title
    Duration of meropenem treatment
    Description
    Total days of meropenem treatment
    Time Frame
    3-28 days
    Title
    Clinical side effects of meropenem treatment
    Description
    Safety of meropenem therapy will be evaluated by clinical symptoms (diarrhea, rash, vomiting and seizures).
    Time Frame
    3-28 days from meropenem treatment
    Title
    Laboratory derangement related to meropenem treatment
    Description
    Assessment of laboratory parameters and their changes during meropenem therapy (transaminases, alkaline phosphatase, bilirubin).
    Time Frame
    3-28 days from meropenem treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Days
    Maximum Age & Unit of Time
    4 Weeks
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Neonates admitted to the neonatal care unit (NCU) who suffer from late onset sepsis (LOS) at admission or during their NICU stay and receive meropenem for at least four days Exclusion Criteria: Acute or chronic renal failure Hypersensitivity or allergy to meropenem

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27918382
    Citation
    Shabaan AE, Nour I, Elsayed Eldegla H, Nasef N, Shouman B, Abdel-Hady H. Conventional Versus Prolonged Infusion of Meropenem in Neonates With Gram-negative Late-onset Sepsis: A Randomized Controlled Trial. Pediatr Infect Dis J. 2017 Apr;36(4):358-363. doi: 10.1097/INF.0000000000001445.
    Results Reference
    derived

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