Community Research and Development Information Service - CORDIS

FP7

NEOMERO — Result In Brief

Project ID: 242146
Funded under: FP7-HEALTH
Country: Italy

Evaluating antibiotics for the treatment of neonatal infections

A European randomised clinical trial evaluated the efficacy of an alternative antibiotic regimen to cure life-threatening bacterial infections in neonates.
Evaluating antibiotics for the treatment of neonatal infections
Neonates admitted to the neonatal intensive care unit are at high risk of contracting hospital-associated bacterial infections, which can progress to sepsis or bacterial meningitis. Apart from long-term disabilities, these two conditions have a mortality rate of up to 30 %, causing serious concern.

Aggressive antibiotic treatment targeting both Gram-positive and -negative bacteria is the current standard practice. The initial therapy is critical for the final prognosis since a delay in rapid sterilisation of the blood and cerebrospinal fluid can lead to relapse or neurological complications. To make matters worse, in recent years many pathogens capable of causing neonatal bacterial sepsis and meningitis have developed high resistance to the antibiotics used in neonates.

To address this problem, scientists of the EU-funded NEOMERO (European multicenter network to evaluate pharmacokinetics, safety and efficacy of meropenem in neonatal sepsis and meningitis) project aimed to test the antibiotic meropenem as an alternative treatment in neonates. Meropenem is generally safe and well tolerated and exhibits very good pharmacokinetic and pharmacodynamic characteristics in children and neonates older than 90 days. However, no information is currently available on its use in neonates and infants aged less than 3 months.

Based on previous models, NEOMERO researchers designed a clinical study to evaluate the safety, pharmacokinetics and efficacy of meropenem against neonatal sepsis and bacterial meningitis. In various centres across Europe, the consortium recruited a total of 271 children, half of whom received meropenem for an average of 8 days.

Clinicians monitored the clinical progression of the neonates through haematological, biochemical and immunological analyses, and performed neurological and developmental evaluations. They also monitored the appearance of resistant bacteria.

Collectively, the NEOMERO trial highlighted the need for testing off-label medications in other age groups not covered in original studies. The specific paediatric use of meropenem at appropriate dosage will ensure that neonates with sepsis or bacterial meningitis are treated safely.

Related information

Keywords

Antibiotics, neonatal, infections, sepsis, bacterial meningitis, NEOMERO, meropenem
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