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

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ClinicalTrials.gov Identifier: NCT02503761
Recruitment Status : Completed
First Posted : July 21, 2015
Last Update Posted : July 21, 2015
Sponsor:
Information provided by (Responsible Party):
Abd Elazeez Attala Shabaan, Mansoura University

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.


Condition or disease Intervention/treatment Phase
Late Onset Neonatal Sepsis Drug: Meropenem. Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bolus Versus Prolonged Infusion of Meropenem in Newborn With Late Onset Sepsis: A Randomized Control Trial
Study Start Date : August 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
Drug Information available for: Meropenem

Arm Intervention/treatment
Active Comparator: Infusion arm
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.
Drug: Meropenem.
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

Active Comparator: Bolus group
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.
Drug: Meropenem.
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 Measures :
  1. Clinical outcome [ Time Frame: 15-28 days from Meropenem treatment ]
    • 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.

  2. Microbiological outcome [ Time Frame: 7-21 days from Meropenem treatment ]
    • 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 :
  1. Meropenem-related length of mechanical ventilation [ Time Frame: 0-31 days from Meropenem treatment ]
    The number of mechanical ventilation days from the start of meropenem administration

  2. Meropenem-related length of NICU stay [ Time Frame: 10 weeks from Meropenem treatment ]
    The number of days from the beginning of meropenem therapy to discharge from NICU

  3. NICU mortality [ Time Frame: 12 weeks from time of admission ]
    Death before discharge

  4. Duration of meropenem treatment [ Time Frame: 3-28 days ]
    Total days of meropenem treatment

  5. Clinical side effects of meropenem treatment [ Time Frame: 3-28 days from meropenem treatment ]
    Safety of meropenem therapy will be evaluated by clinical symptoms (diarrhea, rash, vomiting and seizures).

  6. Laboratory derangement related to meropenem treatment [ Time Frame: 3-28 days from meropenem treatment ]
    Assessment of laboratory parameters and their changes during meropenem therapy (transaminases, alkaline phosphatase, bilirubin).



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abd Elazeez Attala Shabaan, Assistant professor, PhD, Mansoura University
ClinicalTrials.gov Identifier: NCT02503761     History of Changes
Other Study ID Numbers: 67890
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015

Keywords provided by Abd Elazeez Attala Shabaan, Mansoura University:
meropenem
infusion
late-onset sepsis
newborn
management

Additional relevant MeSH terms:
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Sepsis
Toxemia
Neonatal Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Infant, Newborn, Diseases
Meropenem
Anti-Bacterial Agents
Anti-Infective Agents