Bolus Versus Prolonged Infusion of Meropenem in Newborn With Late Onset Sepsis
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.
Timeline
- Start
- 2013-08
- Primary completion
- 2015-06
- Completion
- 2015-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Meropenem | Small molecule | 20 mg/kg | Intravenous |
| Comparator | Meropenem | Small molecule | 40 mg/kg | Intravenous |