Overview

Efficacy, Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days With Clinical or Confirmed Late-onset Sepsis

Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
This phase III multicentric international randomized trial is designed to compare the efficacy of Meropenem to the standard of care in infants below 90 days of age with clinical or confirmed late-onset sepsis (LOS). The aim is to assess efficacy , pharmacokinetics and safety of Meropenem which are not well known and documented in this population.
Phase:
Phase 3
Details
Lead Sponsor:
PENTA Foundation
Collaborator:
Chiesi Farmaceutici S.p.A.
Treatments:
Ampicillin
Cefotaxime
Cefoxitin
Gentamicins
Meropenem
Thienamycins