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