drugset / Trial / NCT01551394
Efficacy, Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days With Clinical or Confirmed Late-onset Sepsis
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2012-09
- Primary completion
- 2014-12
- Completion
- 2014-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ampicillin | Unknown | 50 mg/kg | — |
| Comparator | Cefotaxime | Small molecule | 50 mg/kg | — |
| Comparator | Gentamicin | Small molecule | 5 mg/kg | — |
| Comparator | Gentamicin | Small molecule | 7 mg/kg | — |
| Subject | Meropenem | Small molecule | 20 mg/kg | Other |