Sepsis Clinical Trial
Official title:
Pharmacoeconomic Analysis of First Line Meropenem Versus Standard Antibiotic Treatment in Seriously Infected Secondary Nosocomial Sepsis Syndrome Patients. An Open, Randomized Multi-center Study.
Verified date | August 2017 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 160 |
Est. completion date | June 2006 |
Est. primary completion date | June 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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: |
Country | Name | City | State |
---|---|---|---|
Hungary | Research Site | Baja | |
Hungary | Research Site | Budapest | |
Hungary | Research Site | Eger | |
Hungary | Research Site | Kecskemet | |
Hungary | Research Site | Kistarcsa | |
Hungary | Research Site | Miskolc | |
Hungary | Research Site | Pecs | |
Hungary | Research Site | Siofok | |
Hungary | Research Site | Szekesfehervar | |
Hungary | Research Site | Szolnok | |
Hungary | Research Site | Szombathely | |
Hungary | Research Site | Veszprem |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Hungary,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of days from randomization to recovery from sepsis among those patients who survived the trial period | |||
Primary | Endpoint considered in conjunction with observed mortality rates to determine whether any reduction in time to recovery from sepsis | |||
Secondary | Number of days from randomization to ready to discharge from the ICU | |||
Secondary | Number of days from randomization until patient is discharged from the ICU | |||
Secondary | Number of days on first line antibiotic therapy | |||
Secondary | Number of days from randomization until patient is discharged from hospital | |||
Secondary | Proportion of patients who achieve clinical cure from sepsis following first line antibiotic therapy | |||
Secondary | Proportion of all patients who are ready to discharge from the ICU following antibiotic therapy | |||
Secondary | Mortality rate due to "all causes" in the meropenem group and the standard antibiotic therapy group | |||
Secondary | Mortality rate due to infection in the meropenem group and the standard antibiotic therapy group | |||
Secondary | Health Economics-Resource utilization for main treatment and diagnostic procedures, tools and materials |
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