Sepsis
Conditions
Keywords
Antibiotic Therapy, sepsis treatment, Meropenem
Brief summary
This study will directly compare meropenem with standard first line antibiotic therapies in subjects entering an ICU with secondary nosocomial sepsis, or who contract sepsis while resident in an ICU.
Interventions
DRUGMeropenem
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female subjects aged ≥ 18, requiring intensive care treatment related to secondary nosocomial sepsis, who require potent broad spectrum intravenous antibiotic therapy.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of days from randomization to recovery from sepsis among those patients who survived the trial period | — |
| Endpoint considered in conjunction with observed mortality rates to determine whether any reduction in time to recovery from sepsis | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of days on first line antibiotic therapy | — |
| Number of days from randomization until patient is discharged from hospital | — |
| Proportion of patients who achieve clinical cure from sepsis following first line antibiotic therapy | — |
| Number of days from randomization to ready to discharge from the ICU | — |
| Mortality rate due to all causes in the meropenem group and the standard antibiotic therapy group | — |
| Mortality rate due to infection in the meropenem group and the standard antibiotic therapy group | — |
| Health Economics-Resource utilization for main treatment and diagnostic procedures, tools and materials | — |
| Proportion of all patients who are ready to discharge from the ICU following antibiotic therapy | — |
| Number of days from randomization until patient is discharged from the ICU | — |
Countries
Hungary
Outcome results
None listed