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NCT Number: NCT02503761

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

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.

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Key information

Conditions

Late Onset Neonatal Sepsis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infections Inflammation Neonatal Sepsis Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

3 day–4 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meropenem.

Drug

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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Bolus Versus Prolonged Infusion of Meropenem in Newborn With Late Onset Sepsis: A Randomized Control Trial

Acronym: BVPIMNBLOS

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 21, 2015
Registry last updated
Jul 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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