Pharmacoeconomic Analysis of First Line Meropenem Versus Standard Antibiotic Treatment in Seriously Infected Secondary Nosocomial Sepsis Syndrome Patients.
2 other identifiers
interventional
160
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 sepsis
Started Jan 2002
Longer than P75 for phase_4 sepsis
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedFirst Submitted
Initial submission to the registry
April 25, 2006
CompletedFirst Posted
Study publicly available on registry
April 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedSeptember 1, 2017
August 1, 2017
4.4 years
April 25, 2006
August 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (9)
Number of days from randomization to ready to discharge from the ICU
Number of days from randomization until patient is discharged from the ICU
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
- +4 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Male and female subjects aged ≥ 18, requiring intensive care treatment related to secondary nosocomial sepsis, who require potent broad spectrum intravenous antibiotic therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (12)
Research Site
Baja, Hungary
Research Site
Budapest, Hungary
Research Site
Eger, Hungary
Research Site
Kecskemét, Hungary
Research Site
Kistarcsa, Hungary
Research Site
Miskolc, Hungary
Research Site
Pécs, Hungary
Research Site
Siófok, Hungary
Research Site
Székesfehérvár, Hungary
Research Site
Szolnok, Hungary
Research Site
Szombathely, Hungary
Research Site
Veszprém, Hungary
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca CRR Central and Eastern Europe, Hungary Medical Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 25, 2006
First Posted
April 27, 2006
Study Start
January 1, 2002
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
September 1, 2017
Record last verified: 2017-08