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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mansoura University
• Treatments: Meropenem; Thienamycins

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